The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Micro-albumin Reagent And Calibrator.
| Device ID | K101089 |
| 510k Number | K101089 |
| Device Name: | EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR |
| Classification | Albumin, Antigen, Antiserum, Control |
| 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 | DCF |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-19 |
| Decision Date | 2011-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100002213 | K101089 | 000 |
| 00386100001773 | K101089 | 000 |