The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Creatinine.
| Device ID | K973993 |
| 510k Number | K973993 |
| Device Name: | RANDOX CREATININE |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Contact | P Armstrong |
| Correspondent | P Armstrong RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD Crumlin, IE Bt29 4qy |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-21 |
| Decision Date | 1998-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273208634 | K973993 | 000 |
| 05055273201932 | K973993 | 000 |
| 05055273201918 | K973993 | 000 |
| 05055273201895 | K973993 | 000 |
| 05055273201888 | K973993 | 000 |
| 05055273201901 | K973993 | 000 |