The following data is part of a premarket notification filed by Medica Corporation with the FDA for Easyra Creatinine Reagent.
| Device ID | K123586 |
| 510k Number | K123586 |
| Device Name: | EASYRA CREATININE REAGENT |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | MEDICA CORPORATION 5 OAK PARK DRIVE Bedford, MA 01730 |
| Contact | Photios Makris |
| Correspondent | Photios Makris MEDICA CORPORATION 5 OAK PARK DRIVE Bedford, MA 01730 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2013-05-15 |