The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Rx Daytona Plus Chemistry Analyzer; Rx Daytona Plus Aspartate Aminotransferase (ast) Reagent.
| Device ID | K131554 |
| 510k Number | K131554 |
| Device Name: | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| 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 | JJE |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CIT |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-30 |
| Decision Date | 2014-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273214895 | K131554 | 000 |
| 05055273207781 | K131554 | 000 |
| 05055273208245 | K131554 | 000 |
| 05055273209389 | K131554 | 000 |
| 05055273214307 | K131554 | 000 |
| 05055273214321 | K131554 | 000 |
| 05055273214338 | K131554 | 000 |
| 05055273214345 | K131554 | 000 |
| 05055273214352 | K131554 | 000 |
| 05055273214369 | K131554 | 000 |
| 05055273214376 | K131554 | 000 |
| 05055273214444 | K131554 | 000 |
| 05055273214529 | K131554 | 000 |
| 05055273214857 | K131554 | 000 |
| 05055273214864 | K131554 | 000 |
| 05055273214871 | K131554 | 000 |
| 05055273214888 | K131554 | 000 |
| 05055273207774 | K131554 | 000 |