PREGNANCY BETA-HCG CARD & LIQUID TEST— 510(k) K880478

Name: FDA 510(k) clearance K880478
Creator: U.S. Food and Drug Administration
Published: 1988-04-28

Substantially Equivalent

Ampcor, Inc.

FDA 510(k) clearance K880478 for PREGNANCY BETA-HCG CARD & LIQUID TEST, Substantially Equivalent on 1988-04-28. Applicant: Ampcor, Inc.. Device class: 2.

Clearance details

Applicant: Ampcor, Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1988-02-04
Decision date: 1988-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, NJ, US

Download summary PDF View on FDA.gov ↗

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