VISUALINE II COCAINE— 510(k) K950369

Name: FDA 510(k) clearance K950369
Creator: U.S. Food and Drug Administration
Published: 1995-03-21

Substantially Equivalent

Sun Biomedical Laboratories, Inc.

FDA 510(k) clearance K950369 for VISUALINE II COCAINE, Substantially Equivalent on 1995-03-21. 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: 1995-01-31
Decision date: 1995-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cherry Hill, NJ, US

Download summary PDF View on FDA.gov ↗

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