Medical Device Manufacturer · GB , Crewe

Osmetech - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2001

Recent clearances: OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV), OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Osmetech Microbiology ✕

2 devices

1-2 of 2

Cleared Jan 29, 2003

OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)

Microbiology · 89d

Cleared Nov 30, 2001

OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)

Microbiology · 239d