The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Alkaline Phosphatase, Aspartate Aminotransferase And Amylase Reagents.
| Device ID | K101090 |
| 510k Number | K101090 |
| Device Name: | EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| 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 | CJE |
| Subsequent Product Code | CIT |
| Subsequent Product Code | JFJ |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-19 |
| Decision Date | 2011-05-20 |