510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993557Substantially Equivalent

Autostat II Rheumatoid Factor Iga Elisa

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

K993557 is the FDA 510(k) clearance record for AUTOSTAT II RHEUMATOID FACTOR IGA ELISA, a class II device, cleared for Cogent Diagnotics , Ltd. on under FDA product code DHR (System, Test, Rheumatoid Factor). FDA records list 31 510(k) clearances for Cogent Diagnotics , Ltd., from to . As of , FDA records show no recalls naming K993557.

Clearance record

Decision date
Received
(135 days to decision)
Product code
DHR System, Test, Rheumatoid Factor
Regulation
21 CFR 866.5775
Device class
Class II
Review panel
Immunology
Applicant
Cogent Diagnotics , Ltd. Pentlands Science Park, Midlothian, Scotland, GB
510(k) summary
Statement
Third party review
No

Clearances, product code DHR

Trailing 12 months

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

FDA records show no clearances under product code DHR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DHR, 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