The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Glu-t Reagent, Easyra Glu-h Reagent.
| Device ID | K100187 |
| 510k Number | K100187 |
| Device Name: | EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT |
| Classification | Glucose Oxidase, Glucose |
| 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 | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-22 |
| Decision Date | 2010-05-05 |