Medical Device Manufacturer · US , Rockville , MD

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

6 submissions · 6 cleared · Since 1999

Recent clearances: POC-AS10 AUTO SAMPLER, RAPIRUN H. PYLORI ANTIBODY DETECTION KIT, POCONE INFRARED SPECTROPHOTOMETER

View 6 510(k) Devices ↓ Official Website

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Otsuka Pharmaceutical Co., Ltd. Chemistry ✕

2 devices

1-2 of 2

Cleared Jul 24, 2000

RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY

Chemistry · 116d

Cleared Aug 20, 1999

RLP CHOLESTEROL IMMUNOSEPARATION ASSAY

Chemistry · 142d