ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA— 510(k) K971834

Name: FDA 510(k) clearance K971834
Creator: U.S. Food and Drug Administration
Published: 1997-07-03

Substantially Equivalent

Monobind

FDA 510(k) clearance K971834 for ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA, Substantially Equivalent on 1997-07-03. Applicant: Monobind. Device class: 2.

Clearance details

Applicant: Monobind
Product code: Code JNL
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1997-05-19
Decision date: 1997-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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