Company ยท US
Otsuka Pharmaceutical Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2010. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 9, 2010 | K092817 | POC-AS10 AUTO SAMPLER Otsuka Pharmaceutical Co., Ltd. | MSQ |
| Nov 16, 2006 | K052716 | RAPIRUN H. PYLORI ANTIBODY DETECTION KIT Otsuka Pharmaceutical Co., Ltd. | LYR |
| Jul 15, 2004 | K041148 | POCONE INFRARED SPECTROPHOTOMETER Otsuka Pharmaceutical Co., Ltd. | MSQ |
| Dec 21, 2001 | K013371 | UBIT-IR300 INFRARED SPECTROMETRY SYSTEM Otsuka Pharmaceutical Co., Ltd. | JJQ |
| Jul 24, 2000 | K001032 | RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY Otsuka Pharmaceutical Co., Ltd. | CHH |
| Aug 20, 1999 | K991083 | RLP CHOLESTEROL IMMUNOSEPARATION ASSAY Otsuka Pharmaceutical Co., Ltd. | CHH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||