RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST— 510(k) K984525

Name: FDA 510(k) clearance K984525
Creator: U.S. Food and Drug Administration
Published: 1999-02-26

Substantially Equivalent

American Bio Medica Corp.

FDA 510(k) clearance K984525 for RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST, Substantially Equivalent on 1999-02-26. Applicant: American Bio Medica Corp.. Device class: 2.

Clearance details

Applicant: American Bio Medica Corp.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1998-12-21
Decision date: 1999-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, NY, US

Download summary PDF View on FDA.gov ↗

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