The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Haemoglobin Reagent - Cyanmethaemoglobin Method.
| Device ID | K870363 |
| 510k Number | K870363 |
| Device Name: | HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD |
| Classification | Whole Blood Hemoglobin Determination |
| Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Contact | William C Riddle |
| Correspondent | William C Riddle TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Product Code | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-28 |
| Decision Date | 1987-03-16 |