The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako L-type Creatinine-m Test, And Wako Creatinine Calibrator.
| Device ID | K061775 |
| 510k Number | K061775 |
| Device Name: | WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR |
| Classification | Enzymatic Method, Creatinine |
| Applicant | WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Contact | Lori Creasy |
| Correspondent | Lori Creasy WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Product Code | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-23 |
| Decision Date | 2007-02-23 |
| Summary: | summary |