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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Cocaine And Cocaine Metabolites
510(k) Number K964900
Device Name RAPID DRUG SCREEN
Applicant
American Bio Medica Corp.
102 Simons Rd.
Ancramdale,  NY  12503
Applicant Contact HENRY WELLS
Correspondent
American Bio Medica Corp.
102 Simons Rd.
Ancramdale,  NY  12503
Correspondent Contact HENRY WELLS
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DJG   DKZ   LCM   LDJ  
Date Received11/27/1996
Decision Date 04/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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