The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Opiates Assay.
| Device ID | K041144 |
| 510k Number | K041144 |
| Device Name: | RANDOX OPIATES ASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Contact | P. Armstrong |
| Correspondent | P. Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-30 |
| Decision Date | 2004-11-03 |