IMMUNOWELL RNP/SM ANTIBODY TEST— 510(k) K911848

Substantially Equivalent

General Biometrics, Inc.

FDA 510(k) clearance K911848 for IMMUNOWELL RNP/SM ANTIBODY TEST, Substantially Equivalent on 1991-05-07. Applicant: General Biometrics, Inc..

Clearance details

Applicant: General Biometrics, Inc.
Product code: Code LKP
Advisory panel: Immunology
Date received: 1991-04-26
Decision date: 1991-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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