VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE— 510(k) K993485

Name: FDA 510(k) clearance K993485
Creator: U.S. Food and Drug Administration
Published: 1999-12-27

Substantially Equivalent

Sun Biomedical Laboratories, Inc.

FDA 510(k) clearance K993485 for VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE, Substantially Equivalent on 1999-12-27. Applicant: Sun Biomedical Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Sun Biomedical Laboratories, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1999-10-14
Decision date: 1999-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blackwood, NJ, US

Download summary PDF View on FDA.gov ↗

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