The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Iron.
| Device ID | K974604 |
| 510k Number | K974604 |
| Device Name: | RANDOX IRON |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| 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 | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-10 |
| Decision Date | 1998-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273206227 | K974604 | 000 |
| 05055273206210 | K974604 | 000 |
| 05055273206203 | K974604 | 000 |
| 05055273206197 | K974604 | 000 |
| 05055273206180 | K974604 | 000 |