The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Rx Daytona.
| Device ID | K024014 |
| 510k Number | K024014 |
| Device Name: | RANDOX RX DAYTONA |
| Classification | Glucose Oxidase, Glucose |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Contact | Lynne Hamilton |
| Correspondent | Lynne Hamilton RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Product Code | CGA |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJF |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-04 |
| Decision Date | 2003-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273210552 | K024014 | 000 |
| 05055273205893 | K024014 | 000 |
| 05055273205947 | K024014 | 000 |
| 05055273205954 | K024014 | 000 |
| 05055273205961 | K024014 | 000 |
| 05055273206043 | K024014 | 000 |
| 05055273206050 | K024014 | 000 |
| 05055273206074 | K024014 | 000 |
| 05055273206098 | K024014 | 000 |
| 05055273206111 | K024014 | 000 |
| 05055273206289 | K024014 | 000 |
| 05055273206982 | K024014 | 000 |
| 05055273210361 | K024014 | 000 |
| 05055273210521 | K024014 | 000 |
| 05055273210538 | K024014 | 000 |
| 05055273210545 | K024014 | 000 |
| 05055273205091 | K024014 | 000 |