UNIMARK MIDSTREAM PREGNANCY TEST STICK— 510(k) K960174

Name: FDA 510(k) clearance K960174
Creator: U.S. Food and Drug Administration
Published: 1996-04-01

Substantially Equivalent

Biotech Atlantic, Inc.

FDA 510(k) clearance K960174 for UNIMARK MIDSTREAM PREGNANCY TEST STICK, Substantially Equivalent on 1996-04-01. 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: 1996-01-16
Decision date: 1996-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eatontown, NJ, US

Download summary PDF View on FDA.gov ↗

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K941090 — UNISTEP HCG PREGNANCY TEST STRIP1994-06-02

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