ANTI-THYROGLOBULIN TEST KIT— 510(k) K894203

Substantially Equivalent

Kronus

FDA 510(k) clearance K894203 for ANTI-THYROGLOBULIN TEST KIT, Substantially Equivalent on 1989-07-25. Applicant: Kronus. Device class: 2.

Clearance details

Applicant: Kronus
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1989-06-19
Decision date: 1989-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dana Point, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Kronus

K915428 — KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT1992-03-30
K915429 — KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT1992-03-30
K894364 — MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)1989-07-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.