RAPIDONE-BUPRENORPHINE TEST— 510(k) K060760

Name: FDA 510(k) clearance K060760
Creator: U.S. Food and Drug Administration
Published: 2006-08-07

Substantially Equivalent

American Bio Medica Corp.

FDA 510(k) clearance K060760 for RAPIDONE-BUPRENORPHINE TEST, Substantially Equivalent on 2006-08-07. 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: 2006-03-21
Decision date: 2006-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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