The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Ferritin.
| Device ID | K000662 |
| 510k Number | K000662 |
| Device Name: | RANDOX FERRITIN |
| Classification | Ferritin, Antigen, Antiserum, Control |
| 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 | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-28 |
| Decision Date | 2000-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273203097 | K000662 | 000 |
| 05055273203080 | K000662 | 000 |
| 05055273203073 | K000662 | 000 |