UCP HOME DRUG SCREENING TESTS— 510(k) K091588

Name: FDA 510(k) clearance K091588
Creator: U.S. Food and Drug Administration
Published: 2009-09-04

Substantially Equivalent

Ucp Biosciences, Inc.

FDA 510(k) clearance K091588 for UCP HOME DRUG SCREENING TESTS, Substantially Equivalent on 2009-09-04. Applicant: Ucp Biosciences, Inc.. Device class: 2.

Clearance details

Applicant: Ucp Biosciences, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2009-06-02
Decision date: 2009-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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