THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT— 510(k) K931311

Name: FDA 510(k) clearance K931311
Creator: U.S. Food and Drug Administration
Published: 1993-05-14

Substantially Equivalent

Nichols Institute

FDA 510(k) clearance K931311 for THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT, Substantially Equivalent on 1993-05-14. Applicant: Nichols Institute. Device class: 2.

Clearance details

Applicant: Nichols Institute
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1993-03-15
Decision date: 1993-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

Download summary PDF View on FDA.gov ↗

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