510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943625Substantially Equivalent

Autostat II Anti-Thyroglobulin

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

K943625 is the FDA 510(k) clearance record for AUTOSTAT II ANTI-THYROGLOBULIN, a class II device, cleared for Cogent Diagnotics , Ltd. on under FDA product code DDC (Thyroglobulin, Antigen, Antiserum, Control). FDA records list 31 510(k) clearances for Cogent Diagnotics , Ltd., from to . As of , FDA records show no recalls naming K943625.

Clearance record

Decision date
Received
(149 days to decision)
Product code
DDC Thyroglobulin, Antigen, Antiserum, Control
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 DDC

Trailing 12 months

FDA records hold no clearances under product code DDC in the trailing twelve months.

FDA records show no clearances under product code DDC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DDC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260