125-I TSH RECEPTOR ANTIBODY KIT— 510(k) K863006

Substantially Equivalent

Cronus

FDA 510(k) clearance K863006 for 125-I TSH RECEPTOR ANTIBODY KIT, Substantially Equivalent on 1986-09-08. 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: 1986-08-08
Decision date: 1986-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JZO

K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II2025-10-17
K240469 — Access TPO Antibody2024-08-09
K213517 — Access Thyroglobulin Antibody II2023-09-26
K222610 — Elecsys Anti-Tg2023-09-15
K193313 — Elecsys Anti-TSHR2020-02-27

More clearances from Cronus

K871193 — I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT1987-05-15
K871194 — I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT1987-04-20

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