IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3— 510(k) K902938

Name: FDA 510(k) clearance K902938
Creator: U.S. Food and Drug Administration
Published: 1990-08-09

Substantially Equivalent

General Biometrics, Inc.

FDA 510(k) clearance K902938 for IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3, Substantially Equivalent on 1990-08-09. Applicant: General Biometrics, Inc.. Device class: 2.

Clearance details

Applicant: General Biometrics, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1990-07-03
Decision date: 1990-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.