510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991890Substantially Equivalent

Autostat II Anti-Gbm Elisa, Hy.tec Anti-Gmb Elisa

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

K991890 is the FDA 510(k) clearance record for AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA, a class II device, cleared for Cogent Diagnotics , Ltd. on under FDA product code MVJ (Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)). FDA records list 31 510(k) clearances for Cogent Diagnotics , Ltd., from to . As of , FDA records show no recalls naming K991890.

Clearance record

Decision date
Received
(67 days to decision)
Product code
MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
Regulation
21 CFR 866.5660
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 MVJ

Trailing 12 months

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

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