ONE STEP URINE DRUG OF ABUSE COCAINE TEST— 510(k) K951892

Name: FDA 510(k) clearance K951892
Creator: U.S. Food and Drug Administration
Published: 1995-08-17

Substantially Equivalent

Tcpi, Inc.

FDA 510(k) clearance K951892 for ONE STEP URINE DRUG OF ABUSE COCAINE TEST, Substantially Equivalent on 1995-08-17. Applicant: Tcpi, Inc.. Device class: 2.

Clearance details

Applicant: Tcpi, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1995-04-24
Decision date: 1995-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pompano Beach, FL, US

Download summary PDF View on FDA.gov ↗

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