RAPIDONE - OPIATES TEST— 510(k) K990820

Name: FDA 510(k) clearance K990820
Creator: U.S. Food and Drug Administration
Published: 1999-07-15

Substantially Equivalent

American Bio Medica Corp.

FDA 510(k) clearance K990820 for RAPIDONE - OPIATES TEST, Substantially Equivalent on 1999-07-15. Applicant: American Bio Medica Corp.. Device class: 2.

Clearance details

Applicant: American Bio Medica Corp.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1999-03-11
Decision date: 1999-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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