The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Calcium.
| Device ID | K974607 |
| 510k Number | K974607 |
| Device Name: | RANDOX CALCIUM |
| Classification | Azo Dye, Calcium |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Contact | P. Armstrong |
| Correspondent | P. Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Product Code | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-10 |
| Decision Date | 1998-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273200904 | K974607 | 000 |
| 05055273200881 | K974607 | 000 |