BIOTIS DECARBOXYLASE MEDIA, ORNITHINE

BIOTIS DECARBOXYLASE MEDIA, ORNITHINE is an FDA 510(k)-cleared medical device (K862398) manufactured by Otisville Biotech, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 2, 1986. Regulation: 8.