Otsuka Pharmaceutical Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 23
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K092817 | POC-AS10 AUTO SAMPLER | March 9, 2010 |
| K052716 | RAPIRUN H. PYLORI ANTIBODY DETECTION KIT | November 16, 2006 |
| K041148 | POCONE INFRARED SPECTROPHOTOMETER | July 15, 2004 |
| K013371 | UBIT-IR300 INFRARED SPECTROMETRY SYSTEM | December 21, 2001 |
| K001032 | RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY | July 24, 2000 |
| K991083 | RLP CHOLESTEROL IMMUNOSEPARATION ASSAY | August 20, 1999 |