The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Rx Imola.
| Device ID | K052914 |
| 510k Number | K052914 |
| Device Name: | RX IMOLA |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGJ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-14 |
| Decision Date | 2006-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055273206104 | K052914 | 000 |