The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Calibration Serum.
| Device ID | K053153 |
| 510k Number | K053153 |
| Device Name: | RANDOX CALIBRATION SERUM |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-10 |
| Decision Date | 2006-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273200966 | K053153 | 000 |
| 05055273200959 | K053153 | 000 |