Medical Device Manufacturer · US , Nashville , TN

Meretek Diagnostics, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1996

Recent clearances: BREATHTEK - UBIT UBT FOR H. PYLORI, THE MERETEK UBT BREATH TEST FOR H.PYLORI, MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Meretek Diagnostics, Inc. Microbiology ✕

3 devices

1-3 of 3

Cleared Jan 17, 2002

BREATHTEK - UBIT UBT FOR H. PYLORI

Microbiology · 22d

Cleared Oct 29, 1997

THE MERETEK UBT BREATH TEST FOR H.PYLORI

Microbiology · 127d

Cleared Sep 17, 1996

MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT

Microbiology · 495d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Sep 07, 2026