PRECO PREGNANCY RAPID CARD TEST, HEM #2028— 510(k) K850604

Name: FDA 510(k) clearance K850604
Creator: U.S. Food and Drug Administration
Published: 1985-04-08

Substantially Equivalent

Preco, Inc.

FDA 510(k) clearance K850604 for PRECO PREGNANCY RAPID CARD TEST, HEM #2028, Substantially Equivalent on 1985-04-08. Applicant: Preco, Inc.. Device class: 2.

Clearance details

Applicant: Preco, Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1985-02-15
Decision date: 1985-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, NJ, US

Download summary PDF View on FDA.gov ↗

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