The following data is part of a premarket notification filed by Medica Corporation with the FDA for Easyra Hdl Reagent; Easyra Ldl Reagent; Easyra Chol Reagent; Easyra Trig Reagent.
| Device ID | K111036 |
| 510k Number | K111036 |
| Device Name: | EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | MEDICA CORPORATION 5 OAK PARK DRIVE Bedford, MA 01730 |
| Contact | Photios Makris |
| Correspondent | Photios Makris MEDICA CORPORATION 5 OAK PARK DRIVE Bedford, MA 01730 |
| Product Code | LBS |
| Subsequent Product Code | CDT |
| Subsequent Product Code | CHH |
| Subsequent Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-14 |
| Decision Date | 2011-07-12 |