The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Cocaine Metabolite.
| Device ID | K113751 |
| 510k Number | K113751 |
| Device Name: | RANDOX COCAINE METABOLITE |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Product Code | DIO |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-21 |
| Decision Date | 2012-05-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273208047 | K113751 | 000 |