The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Therapeutic Drug Calibrator.
| Device ID | K012318 |
| 510k Number | K012318 |
| Device Name: | RANDOX THERAPEUTIC DRUG CALIBRATOR |
| Classification | Calibrators, Drug Mixture |
| 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 | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-23 |
| Decision Date | 2001-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597607 | K012318 | 000 |
| 00630414470351 | K012318 | 000 |
| 05055273206470 | K012318 | 000 |