T4 MICROWELL EIA (ENZYME IMMUNOASSAY0— 510(k) K950588

Name: FDA 510(k) clearance K950588
Creator: U.S. Food and Drug Administration
Published: 1995-06-29

Substantially Equivalent

Biomerica, Inc.

FDA 510(k) clearance K950588 for T4 MICROWELL EIA (ENZYME IMMUNOASSAY0, Substantially Equivalent on 1995-06-29. Applicant: Biomerica, Inc.. Device class: 2.

Clearance details

Applicant: Biomerica, Inc.
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1995-02-09
Decision date: 1995-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

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