510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940557Substantially Equivalent

Staphytect-Od

Unipath, Ltd., Bedford Mk41 Oqg, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940557 is the FDA 510(k) clearance record for STAPHYTECT-OD, a class I device, cleared for Unipath , Ltd. on under FDA product code LHJ (Staphylococcus Aureus Protein A Insoluble). FDA records list 73 510(k) clearances for Unipath , Ltd., from to . As of , FDA records show no recalls naming K940557.

Clearance record

Decision date
Received
(171 days to decision)
Product code
LHJ Staphylococcus Aureus Protein A Insoluble
Regulation
21 CFR 866.3700
Device class
Class I
Review panel
Microbiology
Applicant
Unipath , Ltd. Norse Rd., Bedford Mk41 Oqg, GB
510(k) summary
Statement
Third party review
No

Clearances, product code LHJ

Trailing 12 months

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

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