UNIMARK HOME PREGNANCY TEST DEVICE— 510(k) K032992

Name: FDA 510(k) clearance K032992
Creator: U.S. Food and Drug Administration
Published: 2003-11-21

Substantially Equivalent

Biotech Atlantic, Inc.

FDA 510(k) clearance K032992 for UNIMARK HOME PREGNANCY TEST DEVICE, Substantially Equivalent on 2003-11-21. Applicant: Biotech Atlantic, Inc.. Device class: 2.

Clearance details

Applicant: Biotech Atlantic, Inc.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2003-09-25
Decision date: 2003-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eatontown, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.