The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Bicarbonate (co2) Reagent-2 Vial.
| Device ID | K881938 |
| 510k Number | K881938 |
| Device Name: | BICARBONATE (CO2) REAGENT-2 VIAL |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Contact | Ruthven |
| Correspondent | Ruthven TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-09 |
| Decision Date | 1988-06-15 |