RAPID DRUG SCREEN' 8 PANEL— 510(k) K980872

Name: FDA 510(k) clearance K980872
Creator: U.S. Food and Drug Administration
Published: 1998-03-20

Substantially Equivalent

American Bio Medica Corp.

FDA 510(k) clearance K980872 for RAPID DRUG SCREEN' 8 PANEL, Substantially Equivalent on 1998-03-20. 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: 1998-03-06
Decision date: 1998-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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