The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191.
| Device ID | K053131 |
| 510k Number | K053131 |
| Device Name: | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 |
| Classification | Enzymatic Method, Bilirubin |
| 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 | JFM |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-08 |
| Decision Date | 2005-12-30 |
| Summary: | summary |