The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Mg Reagent, Model 10220.
Device ID | K092737 |
510k Number | K092737 |
Device Name: | EASYRA MG REAGENT, MODEL 10220 |
Classification | Photometric Method, Magnesium |
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 | JGJ |
CFR Regulation Number | 862.1495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-08 |
Decision Date | 2009-11-17 |