AQ ONE STEP COCAINE TEST— 510(k) K972384

Name: FDA 510(k) clearance K972384
Creator: U.S. Food and Drug Administration
Published: 1997-08-06

Substantially Equivalent

Bionike Laboratories, Inc.

FDA 510(k) clearance K972384 for AQ ONE STEP COCAINE TEST, Substantially Equivalent on 1997-08-06. Applicant: Bionike Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bionike Laboratories, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1997-06-26
Decision date: 1997-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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