The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Trace Transferrin Reagent.
| Device ID | K932713 |
| 510k Number | K932713 |
| Device Name: | TRACE TRANSFERRIN REAGENT |
| Classification | Antigen, Antiserum, Control, Antithrombin Iii |
| Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Contact | David Johnston |
| Correspondent | David Johnston TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Product Code | DDQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-04 |
| Decision Date | 1993-09-30 |