The following data is part of a premarket notification filed by Sekisui Medical Co., Ltd. with the FDA for Cp3000 Coagulation Analyzer, Coagpia At Reagent, Coagpia Calibrator, Coagpia Control Set.
| Device ID | K173202 |
| 510k Number | K173202 |
| Device Name: | CP3000 Coagulation Analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | Sekisui Medical Co., Ltd. 1-3 Nihonbashi 2-Chome Chuo-ku, JP 103-00227 |
| Contact | Kazunori Saito |
| Correspondent | Shelly Harris Sekisui Diagnostics, LLC 6659 Top Gun Street San Diego, CA 92121 |
| Product Code | JPA |
| Subsequent Product Code | GGN |
| Subsequent Product Code | JBQ |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2018-05-09 |
| Summary: | summary |