The following data is part of a premarket notification filed by Otsuka Pharmaceutical Co., Ltd. with the FDA for Ubit-ir300 Infrared Spectrometry System.
| Device ID | K013371 |
| 510k Number | K013371 |
| Device Name: | UBIT-IR300 INFRARED SPECTROMETRY SYSTEM |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | OTSUKA PHARMACEUTICAL CO., LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia A Sinclair |
| Correspondent | Cynthia A Sinclair OTSUKA PHARMACEUTICAL CO., LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-11 |
| Decision Date | 2001-12-21 |
| Summary: | summary |