CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name American Bio Medica Rapid TOX   Document Number K053359 Analyte Name Buprenorphine Analyte Specialty Toxicology / TDM Complexity WAIVED Effective Date 08/18/2008 Device Classification Name enzyme immunoassay, amphetamine 510(k) Number K053359 Device Name RAPIDTOX Applicant AMERICAN BIO MEDICA CORP. 163 cabot st. beverly,  MA  01915 Contact fran white Regulation Number 862.3100 Classification Product Code DKZ   Subsequent Product Codes DIO   DIS   DJC   DJG   DJR   JXM   JXN   LCM   LDJ   LFG   Date Received 12/05/2005 Decision Date 05/25/2006 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Toxicology Review Advisory Committee Toxicology Statement/Summary/Purged Status Statement only statement statement FDA Review Decision Summary Type Special Reviewed by Third Party No Expedited Review No