RAPIDONE-AMPHETAMINE TEST— 510(k) K992452

Name: FDA 510(k) clearance K992452
Creator: U.S. Food and Drug Administration
Published: 1999-10-18

Substantially Equivalent

American Bio Medica Corp.

FDA 510(k) clearance K992452 for RAPIDONE-AMPHETAMINE TEST, Substantially Equivalent on 1999-10-18. Applicant: American Bio Medica Corp.. Device class: 2.

Clearance details

Applicant: American Bio Medica Corp.
Product code: Code DOD
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1999-07-22
Decision date: 1999-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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