510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971663Substantially Equivalent

Wellcolex E.coli O157:h7

Murex Biotech, Ltd., Dartford,Kent, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971663 is the FDA 510(k) clearance record for WELLCOLEX E.COLI O157:H7, a class I device, cleared for Murex Biotech , Ltd. on under FDA product code GMZ (Antigens, All Types, Escherichia Coli). FDA records list one 510(k) clearance for Murex Biotech , Ltd. As of , FDA records show no recalls naming K971663.

Clearance record

Decision date
Received
(238 days to decision)
Product code
GMZ Antigens, All Types, Escherichia Coli
Regulation
21 CFR 866.3255
Device class
Class I
Review panel
Microbiology
Applicant
Murex Biotech , Ltd. Central Rd., Temple Hill, Dartford,Kent, GB
510(k) summary
Statement
Third party review
No

Clearances, product code GMZ

Trailing 12 months

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

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