MODIFIED LH ENZYME IMMUNOASSAY TEST KIT— 510(k) K896642

Name: FDA 510(k) clearance K896642
Creator: U.S. Food and Drug Administration
Published: 1990-01-30

Substantially Equivalent

Medix Biotech, Inc.

FDA 510(k) clearance K896642 for MODIFIED LH ENZYME IMMUNOASSAY TEST KIT, Substantially Equivalent on 1990-01-30. Applicant: Medix Biotech, Inc.. Device class: 1.

Clearance details

Applicant: Medix Biotech, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1989-11-24
Decision date: 1990-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

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