The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Metabolite (eddp) Assay.
| Device ID | K092258 |
| 510k Number | K092258 |
| Device Name: | RANDOX METABOLITE (EDDP) ASSAY |
| Classification | Enzyme Immunoassay, Methadone |
| 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 | DJR |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DKB |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-28 |
| Decision Date | 2010-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273208061 | K092258 | 000 |
| 05055273207927 | K092258 | 000 |
| 05055273207910 | K092258 | 000 |
| 05055273207866 | K092258 | 000 |