Rapid Tox Cup II

Gas 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 Ii.

Pre-market Notification Details

• Device ID: K170222
• 510k Number: K170222
• Device Name: Rapid Tox Cup II
• Classification: Gas Chromatography, Methamphetamine
• Applicant: AMERICAN BIO MEDICA CORP. 122 SMITH ROAD Kinderhook, NY 12106
• Contact: Melissa Waterhouse
• Correspondent: Melissa Waterhouse; AMERICAN BIO MEDICA CORP. 122 SMITH ROAD Kinderhook, NY 12106
• Product Code: LAF
• Subsequent Product Code: DIO
• Subsequent Product Code: DIS
• Subsequent Product Code: DJG
• Subsequent Product Code: DJR
• Subsequent Product Code: DKZ
• Subsequent Product Code: JXM
• Subsequent Product Code: LCM
• Subsequent Product Code: LDJ
• Subsequent Product Code: LFG
• CFR Regulation Number: 862.3610 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-25
• Decision Date: 2017-08-15
• Summary: summary