The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Total Bilirubin Reagent, Concentrated.
| Device ID | K890070 |
| 510k Number | K890070 |
| Device Name: | TOTAL BILIRUBIN REAGENT, CONCENTRATED |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Contact | P. J Ruthven |
| Correspondent | P. J Ruthven TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-09 |
| Decision Date | 1989-03-06 |