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Documents FDA 510K Clearance Certification K033047 Oxycodone (OXY) Drug Screening Kits

FEB 1.7 Z004, 8. 510(k) SUMMARY '. This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR…

Documents FDA 510K Clearance Certification K032903 Cocaine (COC) 150 Drug Testing Kits

FEB *i, 7 20V.r 8. 5 10(k) SUMMARY This summary of safety and effectiveness information is being submitted in accordance with the requirements of SM4DA 1990 and 21 CFR 807.92.…

Documents FDA 510K Clearance Documentation for Breath Scan K060761 Drug Testing Kits

K o/o7 I Akers Biosciences, Inc. BreathScanÂ® Alcohol Detector 510(k) Notification SECTION 5. 510(k) SUMMARY STATEMENT 5.1 Date: April 25, 2006 5.2 Submitter: Name: Akers…

Documents FDA 510K Clearance Certification K021526 Tri-Cyclic Anti-Depressants (TCA) Drug Testing Kits

J 8. SUMMARY OF510(k) This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The Assigned…

Documents Development of Diagnostic Pan-Enterovirus Monoclonal Antibodies Using VP1 Recombinant Proteins

DEVELOPMENT OF DIAGNOSTIC PAN-ENTEROVIRUS MONOCLONAL ANTIBODIES USING VP1 RECOMBINANT PROTEINS Lynn Yihong Miao, Christina Pierce, Sarah Peaslee, Carl Shaw, April Brandon,…

Documents 510(k) Submissions Recent Experience and Perspectives

510(k) Submissions Recent Experience and Perspectives Terry Sullivan Vice President, Regulatory Affairs * What I will cover today... Survey of audience Overview of 510(k)…