The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Cannabinoid Assay And The Randox Cannabinoid Calibrator/ Control Set.
| Device ID | K092269 |
| 510k Number | K092269 |
| Device Name: | CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET |
| Classification | Enzyme Immunoassay, Cannabinoids |
| 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 | LDJ |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-28 |
| Decision Date | 2011-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273208030 | K092269 | 000 |
| 05055273207965 | K092269 | 000 |
| 05055273207958 | K092269 | 000 |
| 05055273207842 | K092269 | 000 |