The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Tbil Reagent, Easyra Dbii Reagent, Easyra Ck Reagent.
| Device ID | K123802 |
| 510k Number | K123802 |
| Device Name: | EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-03-01 |