ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST— 510(k) K981197

Name: FDA 510(k) clearance K981197
Creator: U.S. Food and Drug Administration
Published: 1998-06-16

Substantially Equivalent

Tcpi, Inc.

FDA 510(k) clearance K981197 for ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST, Substantially Equivalent on 1998-06-16. Applicant: Tcpi, Inc.. Device class: 2.

Clearance details

Applicant: Tcpi, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1998-04-02
Decision date: 1998-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

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