MODIFICATION TO RAPID DRUG SCREEN 9-PANEL— 510(k) K002447

Name: FDA 510(k) clearance K002447
Creator: U.S. Food and Drug Administration
Published: 2000-11-16

Substantially Equivalent

American Bio Medica Corp.

FDA 510(k) clearance K002447 for MODIFICATION TO RAPID DRUG SCREEN 9-PANEL, Substantially Equivalent on 2000-11-16. 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: 2000-08-09
Decision date: 2000-11-16
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.