510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011043Substantially Equivalent

Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti)

Opti Medical Systems Inc, Crewe, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011043 is the FDA 510(k) clearance record for OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI), a class I device, cleared for Osmetech on under FDA product code JXA (Kit, Screening, Urine). FDA records list 7 510(k) clearances for OPTI MEDICAL SYSTEMS INC., from to . As of , FDA records show no recalls naming K011043.

Clearance record

Decision date
Received
(239 days to decision)
Product code
JXA Kit, Screening, Urine
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Osmetech Electra House, Electra Way, Crewe, GB
510(k) summary
Summary
Third party review
No

Clearances, product code JXA

Trailing 12 months

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

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