The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Albumin, Calcium, Magnesium And Inorganic Phosphorous Reagent.
| Device ID | K101088 |
| 510k Number | K101088 |
| Device Name: | EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT |
| Classification | Bromcresol Green Dye-binding, Albumin |
| 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 | CIX |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CJY |
| Subsequent Product Code | JGJ |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-19 |
| Decision Date | 2011-04-04 |