The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Iron Reagent.
Device ID | K874055 |
510k Number | K874055 |
Device Name: | IRON REAGENT |
Classification | Ferrozine (colorimetric) Iron Binding Capacity |
Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
Contact | A. P Bigum |
Correspondent | A. P Bigum 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 | 1987-10-05 |
Decision Date | 1987-10-28 |