The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Iron 5 X Conc Reagent.
| Device ID | K904116 |
| 510k Number | K904116 |
| Device Name: | IRON 5 X CONC REAGENT |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| 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 | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-06 |
| Decision Date | 1990-09-27 |