ORGENTEC ANTI-TPO ELISA— 510(k) K952129

Name: FDA 510(k) clearance K952129
Creator: U.S. Food and Drug Administration
Published: 1995-06-20

Substantially Equivalent

American Laboratory Products Co., Ltd.

FDA 510(k) clearance K952129 for ORGENTEC ANTI-TPO ELISA, Substantially Equivalent on 1995-06-20. Applicant: American Laboratory Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: American Laboratory Products Co., Ltd.
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1995-05-08
Decision date: 1995-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, NH, US

Download summary PDF View on FDA.gov ↗

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