The following data is part of a premarket notification filed by Randox Laboratories Limited with the FDA for Randox Tri Level Cardiac Control.
| Device ID | K041361 |
| 510k Number | K041361 |
| Device Name: | RANDOX TRI LEVEL CARDIAC CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD CRUMLIN CO ANTRIM Crumlin, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD CRUMLIN CO ANTRIM Crumlin, GB Bt29 4qy |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-21 |
| Decision Date | 2004-09-09 |