The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Inorganic Phosphorous.
| Device ID | K974605 |
| 510k Number | K974605 |
| Device Name: | RANDOX INORGANIC PHOSPHOROUS |
| Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| 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 | CEO |
| CFR Regulation Number | 862.1580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-10 |
| Decision Date | 1998-01-09 |