The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Urea Nitrogen And Creatinine Reagents.
| Device ID | K110675 |
| 510k Number | K110675 |
| Device Name: | EASYRA UREA NITROGEN AND CREATININE REAGENTS |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | MEDICA CORP. 5 OAK PARK DRIVE Bedford, MA 01730 |
| Contact | Photios Makris |
| Correspondent | Photios Makris MEDICA CORP. 5 OAK PARK DRIVE Bedford, MA 01730 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-10 |
| Decision Date | 2011-04-21 |
| Summary: | summary |