ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY— 510(k) K962926

Name: FDA 510(k) clearance K962926
Creator: U.S. Food and Drug Administration
Published: 1996-10-10

Substantially Equivalent

American Laboratory Products Co., Ltd.

FDA 510(k) clearance K962926 for ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY, Substantially Equivalent on 1996-10-10. Applicant: American Laboratory Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: American Laboratory Products Co., Ltd.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1996-07-29
Decision date: 1996-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, NH, US

Download summary PDF View on FDA.gov ↗

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