The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Human Asssayed Drug Control.
| Device ID | K012319 |
| 510k Number | K012319 |
| Device Name: | RANDOX HUMAN ASSSAYED DRUG CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
| Contact | P. Armstrong |
| Correspondent | P. Armstrong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, Co. Antrim, GB Bt29 4qy |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-23 |
| Decision Date | 2001-08-24 |