510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033744Substantially Equivalent

Autostat II Anti-Tisue Transglutaminase Iga Elisa

Hycor Biomedical, Penicuik, Midlothian, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K033744 is the FDA 510(k) clearance record for AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA, a class II device, cleared for Hycor Biomedical , Ltd. on under FDA product code MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)). FDA records list 66 510(k) clearances for Hycor Biomedical , Ltd., from to . As of , FDA records show no recalls naming K033744.

Clearance record

Decision date
Received
(50 days to decision)
Product code
MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Hycor Biomedical , Ltd. Pentlands Science Park, Penicuik, Midlothian, GB
510(k) summary
Statement
Third party review
No

Clearances, product code MVM

Trailing 12 months

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

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