UNIMARK HOME PREGNANCY TEST DEVICE— 510(k) K032992

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..

Clearance details

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

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