510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943580Substantially Equivalent

Autostat II Anti-Tpo

Cogent Diagnotics, Ltd., Edinburgh, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943580 is the FDA 510(k) clearance record for AUTOSTAT II ANTI-TPO, a class II device, cleared for Cogent Diagnotics , Ltd. on under FDA product code JNL (Immunochemical, Thyroglobulin Autoantibody). FDA records list 31 510(k) clearances for Cogent Diagnotics , Ltd., from to . As of , FDA records show no recalls naming K943580.

Clearance record

Decision date
Received
(269 days to decision)
Product code
JNL Immunochemical, Thyroglobulin Autoantibody
Regulation
21 CFR 866.5870
Device class
Class II
Review panel
Immunology
Applicant
Cogent Diagnotics , Ltd. Kings Bldg.S, W. Mains Rd., Edinburgh, GB
510(k) summary
Statement
Third party review
No

Clearances, product code JNL

Trailing 12 months
1 clearance under product code JNL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JNL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260