The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako(tm) Autokit Crp.
| Device ID | K895598 |
| 510k Number | K895598 |
| Device Name: | WAKO(TM) AUTOKIT CRP |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Contact | Toshihiko Oda |
| Correspondent | Toshihiko Oda WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-18 |
| Decision Date | 1989-09-27 |