The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Direct Bilirubin V.
| Device ID | K970986 |
| 510k Number | K970986 |
| Device Name: | WAKO DIRECT BILIRUBIN V |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Contact | Tonya Mallory |
| Correspondent | Tonya Mallory WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-18 |
| Decision Date | 1997-05-07 |
| Summary: | summary |