I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT— 510(k) K871194

Name: FDA 510(k) clearance K871194
Creator: U.S. Food and Drug Administration
Published: 1987-04-20

Substantially Equivalent

Cronus

FDA 510(k) clearance K871194 for I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT, Substantially Equivalent on 1987-04-20. Applicant: Cronus. Device class: 2.

Clearance details

Applicant: Cronus
Product code: Code DBL
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1987-03-24
Decision date: 1987-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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K871193 — I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT1987-05-15
K863006 — 125-I TSH RECEPTOR ANTIBODY KIT1986-09-08

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