
Otsuka Pharmaceutical Co., Ltd.
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UBIT-IR300 INFRARED SPECTROMETRY SYSTEM is an FDA 510(k)-cleared medical device (K013371) manufactured by Otsuka Pharmaceutical Co., Ltd.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 20, 2001. Regulation: 8.