The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Trace Total/direct Bilirubin Reagent.
| Device ID | K911866 |
| 510k Number | K911866 |
| Device Name: | TRACE TOTAL/DIRECT BILIRUBIN REAGENT |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Contact | Peter Murphy |
| Correspondent | Peter Murphy 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 | 1991-04-26 |
| Decision Date | 1991-07-17 |