Otsuka Pharmaceutical Co., Ltd. - FDA 510(k) Cleared Devices

Otsuka Pharmaceutical Co., Ltd. is a global pharmaceutical and healthcare company with a manufacturing facility in Rockville, US. The company develops medical devices, pharmaceuticals, and nutritional products across multiple therapeutic areas.

Otsuka received 6 FDA 510(k) clearances from 6 total submissions, with no denied submissions on record. The company's cleared devices span microbiology and chemistry categories, including diagnostic assays and spectrophotometry systems. Clearances were granted between 1999 and 2010.

The company is inactive in the FDA 510(k) database, with no submissions recorded in the past 15 years. This regulatory record reflects historical device development activity rather than current market presence in these categories.

Explore the complete list of device names, product codes, and clearance dates in the FDA 510(k) database to review Otsuka's specific submissions and cleared products.