I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT— 510(k) K871193

Name: FDA 510(k) clearance K871193
Creator: U.S. Food and Drug Administration
Published: 1987-05-15

Substantially Equivalent

Cronus

FDA 510(k) clearance K871193 for I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT, Substantially Equivalent on 1987-05-15. Applicant: Cronus. Device class: 2.

Clearance details

Applicant: Cronus
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1987-03-24
Decision date: 1987-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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K871194 — I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT1987-04-20
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