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 |