RAPID TOX CUP

High Pressure Liquid Chromatography, Methamphetamine

AMERICAN BIO MEDICA CORP.

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

Pre-market Notification Details

• Device ID: K073078
• 510k Number: K073078
• Device Name: RAPID TOX CUP
• Classification: High Pressure Liquid Chromatography, Methamphetamine
• Applicant: AMERICAN BIO MEDICA CORP. 603 HERON DR. UNIT 3 Logan Township, NJ 08085
• Contact: Rich Reilly
• Correspondent: Rich Reilly; AMERICAN BIO MEDICA CORP. 603 HERON DR. UNIT 3 Logan Township, NJ 08085
• Product Code: LAG
• Subsequent Product Code: DIO
• Subsequent Product Code: DJG
• Subsequent Product Code: DJR
• Subsequent Product Code: DKE
• Subsequent Product Code: DKZ
• Subsequent Product Code: JXM
• Subsequent Product Code: JXN
• Subsequent Product Code: LCM
• Subsequent Product Code: LFI
• CFR Regulation Number: 862.3610 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-10-31
• Decision Date: 2008-05-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10694644200499	K073078	000
10694644200505	K073078	000
10694644450726	K073078	000
10694644450733	K073078	000
10694644450740	K073078	000