The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Total Bilirubin Standard Calibrator.
| Device ID | K872263 |
| 510k Number | K872263 |
| Device Name: | TOTAL BILIRUBIN STANDARD CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | WAKO CHEMICALS, USA, INC. 12300 FORD RD. SUITE 130 Dallas, TX 75234 |
| Contact | Toshihiko Oda |
| Correspondent | Toshihiko Oda WAKO CHEMICALS, USA, INC. 12300 FORD RD. SUITE 130 Dallas, TX 75234 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-12 |
| Decision Date | 1987-07-22 |