Medical Device Manufacturer · US , Rockville , MD

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

6 submissions · 6 cleared · Since 1999

6

Total

6

Cleared

0

Denied

Otsuka Pharmaceutical Co., Ltd. has 6 FDA 510(k) cleared medical devices. Based in Rockville, US.

Historical record: 6 cleared submissions from 1999 to 2010. Primary specialty: Microbiology.

Browse the FDA 510(k) cleared devices submitted by Otsuka Pharmaceutical Co., Ltd. Filter by specialty or product code using the sidebar.

6 devices

1–6 of 6

POC-AS10 AUTO SAMPLER

K092817 · MSQ Test, Urea (breath Or Blood) · Microbiology

RAPIRUN H. PYLORI ANTIBODY DETECTION KIT

K052716 · LYR Helicobacter Pylori · Microbiology

POCONE INFRARED SPECTROPHOTOMETER

K041148 · MSQ Test, Urea (breath Or Blood) · Microbiology

UBIT-IR300 INFRARED SPECTROMETRY SYSTEM

K013371 · JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use · Microbiology

RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY

K001032 · CHH Enzymatic Esterase--oxidase, Cholesterol · Chemistry

RLP CHOLESTEROL IMMUNOSEPARATION ASSAY

K991083 · CHH Enzymatic Esterase--oxidase, Cholesterol · Chemistry