PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED)— 510(k) K920345

Name: FDA 510(k) clearance K920345
Creator: U.S. Food and Drug Administration
Published: 1992-03-18

Substantially Equivalent

Medix Biotech, Inc.

FDA 510(k) clearance K920345 for PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED), Substantially Equivalent on 1992-03-18. Applicant: Medix Biotech, Inc.. Device class: 1.

Clearance details

Applicant: Medix Biotech, Inc.
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1992-01-27
Decision date: 1992-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

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