'RAPID DRUG SCREEN' 9-PANEL— 510(k) K983770

Name: FDA 510(k) clearance K983770
Creator: U.S. Food and Drug Administration
Published: 1998-12-31

Substantially Equivalent

American Bio Medica Corp.

FDA 510(k) clearance K983770 for 'RAPID DRUG SCREEN' 9-PANEL, Substantially Equivalent on 1998-12-31. Applicant: American Bio Medica Corp.. Device class: 2.

Clearance details

Applicant: American Bio Medica Corp.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1998-10-26
Decision date: 1998-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.