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Substantial equivalence
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151	510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k102210 Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2011-01-04 12:58:06 Chemistry Anorectics Immunologic tests Amphetamines Dopamine agonists Immunoassay ELISA Methamphetamine Dextroamphetamine Medicine Euphoriants Pharmacology
152	510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k091612 Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2010-03-04 13:00:10 Pharmacology Anorectics Stimulants Dopamine agonists Monoamine oxidase inhibitors Drug test Cocaine Buprenorphine Urinalysis Chemistry Medicine Euphoriants
153	510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION CHECKLIST Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2009-03-04 13:03:45 Medical tests Drug control law Drug test Employment ELISA Oxycodone Immunoassay Tetrahydrocannabinol Assay Chemistry Immunologic tests Euphoriants
154	news Call for tighter controls on transgenic foods A senior panel of scientific experts has surprised Canadian regulators — and many Canadians — by calling for far tighter regulation of genetically modified (GM) foo Add to Reading List Source URL: www.nature.com Language: English - Date: 2009-04-23 11:10:59 Environmental issues Knowledge Science and technology in the United Kingdom Food industry Genetically modified food Genetically modified organism Substantial equivalence UK Research Councils Particle Physics and Astronomy Research Council Genetic engineering Biology Science
155	Reports on Substantial Equivalence (905(j)(1)(A)(i) Reports): An Update Add to Reading List Source URL: www.fda.gov Language: English Clinical pharmacology Pharmacology Therapeutics United States Public Health Service Health Substantial equivalence Food and Drug Administration Clinical research Pharmaceutical sciences
156	FDAAA Section 913 Supply Chain Security Add to Reading List Source URL: www.fda.gov Language: English Substantial equivalence Food and Drug Administration Tobacco industry Regulation of tobacco by the U.S. Food and Drug Administration Tobacco Health policy Pharmacology
157	AMERICAN AXLE & MANUFACTURING Add to Reading List Source URL: www.fda.gov Language: English Medicine Food law Family Smoking Prevention and Tobacco Control Act Tobacco industry Substantial equivalence Electronic cigarette Center for Tobacco Products Federal Food Drug and Cosmetic Act Cigarette Food and Drug Administration Tobacco Health
158	PDF Document Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-07-11 13:10:23 Food science Environmental issues Environment European Union law Food industry Genetically modified food Genetically modified organism Novel food Substantial equivalence Genetic engineering Food and drink Biology
159	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Federal Food Drug and Cosmetic Act Medical device Center for Devices and Radiological Health Humanitarian Device Exemption Clinical trial Substantial equivalence Investigational Device Exemption Food and Drug Administration Medicine Health
160	` 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2012-04-11 15:52:34 Microbiology Immune system Viruses Glycoproteins Inbios Virology ELISA West Nile virus Immunoglobulin M Biology Medicine Immunologic tests

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