ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN— 510(k) K844914

Name: FDA 510(k) clearance K844914
Creator: U.S. Food and Drug Administration
Published: 1985-02-12

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K844914 for ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN, Substantially Equivalent on 1985-02-12. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1984-12-18
Decision date: 1985-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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