RAPID READER

Enzyme Immunoassay, Amphetamine

AMERICAN BIO MEDICA CORP.

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

Pre-market Notification Details

• Device ID: K041696
• 510k Number: K041696
• Device Name: RAPID READER
• Classification: Enzyme Immunoassay, Amphetamine
• Applicant: AMERICAN BIO MEDICA CORP. 163 CABOT ST. Beverly, MA 01915
• Contact: Fran White
• Correspondent: Fran White; AMERICAN BIO MEDICA CORP. 163 CABOT ST. Beverly, MA 01915
• Product Code: DKZ
• Subsequent Product Code: DIO
• Subsequent Product Code: DIS
• Subsequent Product Code: DJC
• Subsequent Product Code: DJG
• Subsequent Product Code: DJR
• Subsequent Product Code: DPK
• Subsequent Product Code: JXM
• Subsequent Product Code: JXN
• Subsequent Product Code: KHO
• Subsequent Product Code: LCM
• Subsequent Product Code: LDJ
• Subsequent Product Code: LFG
• CFR Regulation Number: 862.3100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-06-22
• Decision Date: 2005-07-12
• Summary: summary