IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST— 510(k) K920401

Name: FDA 510(k) clearance K920401
Creator: U.S. Food and Drug Administration
Published: 1992-08-20

Substantially Equivalent

General Biometrics, Inc.

FDA 510(k) clearance K920401 for IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST, Substantially Equivalent on 1992-08-20. Applicant: General Biometrics, Inc.. Device class: 2.

Clearance details

Applicant: General Biometrics, Inc.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1992-01-29
Decision date: 1992-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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