RAPID DRUG SCREEN

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

AMERICAN BIO MEDICA CORP.

The following data is part of a premarket notification filed by American Bio Medica Corp. with the FDA for Rapid Drug Screen.

Pre-market Notification Details

• Device ID: K964900
• 510k Number: K964900
• Device Name: RAPID DRUG SCREEN
• Classification: Enzyme Immunoassay, Cocaine And Cocaine Metabolites
• Applicant: AMERICAN BIO MEDICA CORP. 102 SIMONS RD. Ancramdale, NY 12503
• Contact: Henry Wells
• Correspondent: Henry Wells; AMERICAN BIO MEDICA CORP. 102 SIMONS RD. Ancramdale, NY 12503
• Product Code: DIO
• Subsequent Product Code: DJG
• Subsequent Product Code: DKZ
• Subsequent Product Code: LCM
• Subsequent Product Code: LDJ
• CFR Regulation Number: 862.3250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-11-27
• Decision Date: 1997-04-14