The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Phenobarbital.
| Device ID | K011303 |
| 510k Number | K011303 |
| Device Name: | RANDOX PHENOBARBITAL |
| Classification | Enzyme Immunoassay, Phenobarbital |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Product Code | DLZ |
| CFR Regulation Number | 862.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-30 |
| Decision Date | 2001-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414527215 | K011303 | 000 |
| 00630414527208 | K011303 | 000 |
| 00630414527192 | K011303 | 000 |
| 05055273206401 | K011303 | 000 |