The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Phenytoin.
| Device ID | K011393 |
| 510k Number | K011393 |
| Device Name: | RANDOX PHENYTOIN |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Contact | P. Armstrong |
| Correspondent | P. Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Product Code | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-07 |
| Decision Date | 2001-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414209135 | K011393 | 000 |
| 00630414209128 | K011393 | 000 |
| 00630414121772 | K011393 | 000 |
| 00630414121765 | K011393 | 000 |
| 00630414121758 | K011393 | 000 |
| 05055273206418 | K011393 | 000 |