RAPIDONE-OXY TEST— 510(k) K014101

Substantially Equivalent

American Bio Medica Corp.

FDA 510(k) clearance K014101 for RAPIDONE-OXY TEST, Substantially Equivalent on 2002-03-20. 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: 2001-12-13
Decision date: 2002-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, 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.