The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easy Ra D Bil Reagent Model 10212, Easy Ra Glu-h Reagent Model 10200.
| Device ID | K091991 |
| 510k Number | K091991 |
| Device Name: | EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-02 |
| Decision Date | 2009-09-04 |