RAPID DRUG SCREEN— 510(k) K964900

Substantially Equivalent

American Bio Medica Corp.

FDA 510(k) clearance K964900 for RAPID DRUG SCREEN, Substantially Equivalent on 1997-04-14. Applicant: American Bio Medica Corp.. Device class: 2.

Clearance details

Applicant: American Bio Medica Corp.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1996-11-27
Decision date: 1997-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ancramdale, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.