510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955067Substantially Equivalent

Clearview C. Diff a

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

K955067 is the FDA 510(k) clearance record for CLEARVIEW C. DIFF A, a class I device, cleared for Unipath , Ltd. on under FDA product code MCB (Antigen, C. Difficile). FDA records list 73 510(k) clearances for Unipath , Ltd., from to . As of , FDA records show no recalls naming K955067.

Clearance record

Decision date
Received
(312 days to decision)
Product code
MCB Antigen, C. Difficile
Regulation
21 CFR 866.2660
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 MCB

Trailing 12 months

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

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