EARLY IN HOME PREGNANCY TEST— 510(k) K832599

Name: FDA 510(k) clearance K832599
Creator: U.S. Food and Drug Administration
Published: 1983-09-20

Substantially Equivalent

Warner-Lambert Co.

FDA 510(k) clearance K832599 for EARLY IN HOME PREGNANCY TEST, Substantially Equivalent on 1983-09-20. Applicant: Warner-Lambert Co.. Device class: 2.

Clearance details

Applicant: Warner-Lambert Co.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1983-08-02
Decision date: 1983-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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