RAPIDTOX— 510(k) K053359

Substantially Equivalent

American Bio Medica Corp.

FDA 510(k) clearance K053359 for RAPIDTOX, Substantially Equivalent on 2006-05-25. 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: 2005-12-02
Decision date: 2006-05-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Beverly, MA, 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.