The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Total Co2.
| Device ID | K951221 |
| 510k Number | K951221 |
| Device Name: | TOTAL CO2 |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland, IR |
| Contact | John Lamont |
| Correspondent | John Lamont RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland, IR |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-20 |
| Decision Date | 1996-02-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273208375 | K951221 | 000 |
| 05055273201086 | K951221 | 000 |
| 05055273201031 | K951221 | 000 |
| 05055273201024 | K951221 | 000 |
| 05055273201017 | K951221 | 000 |