APL IGA ELISA KIT— 510(k) K021398

Name: FDA 510(k) clearance K021398
Creator: U.S. Food and Drug Administration
Published: 2002-08-27

Substantially Equivalent

Louisville Apl Diagnostics, Inc.

FDA 510(k) clearance K021398 for APL IGA ELISA KIT, Substantially Equivalent on 2002-08-27. Applicant: Louisville Apl Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Louisville Apl Diagnostics, Inc.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2002-05-02
Decision date: 2002-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Doraville, GA, US

Download summary PDF View on FDA.gov ↗

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