The following data is part of a premarket notification filed by Randox Laboratories Limited with the FDA for Randox Opiates Assay.
| Device ID | K113747 |
| 510k Number | K113747 |
| Device Name: | RANDOX OPIATES ASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD Crumlin, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD Crumlin, GB Bt29 4qy |
| Product Code | DJG |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-20 |
| Decision Date | 2012-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273208054 | K113747 | 000 |