THE MERETEK UBT BREATH TEST FOR H.PYLORI

THE MERETEK UBT BREATH TEST FOR H.PYLORI is an FDA 510(k)-cleared medical device (K972352) manufactured by Meretek Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 28, 1997. Regulation: 8.