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 |