'RAPIDTEC 4' TEST— 510(k) K041712

Substantially Equivalent

American Bio Medica Corp.

FDA 510(k) clearance K041712 for 'RAPIDTEC 4' TEST, Substantially Equivalent on 2004-11-03. Applicant: American Bio Medica Corp..

Clearance details

Applicant: American Bio Medica Corp.
Product code: Code DIS
Advisory panel: Clinical Toxicology
Date received: 2004-06-23
Decision date: 2004-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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