The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Liquid Protein Calibrator.
| Device ID | K031608 |
| 510k Number | K031608 |
| Device Name: | RANDOX LIQUID PROTEIN CALIBRATOR |
| Classification | Calibrator, Multi-analyte 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 | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-22 |
| Decision Date | 2003-08-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273204049 | K031608 | 000 |