The following data is part of a premarket notification filed by Medica Corporation with the FDA for Easyra Ck-mb Reagent, Easyra Crp Reagent, Easy Cal Crp Calibrator Kit, Easyqc Crp Quality Control Material.
| Device ID | K130080 |
| 510k Number | K130080 |
| Device Name: | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| 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 | JHY |
| Subsequent Product Code | DCK |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-14 |
| Decision Date | 2014-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100002244 | K130080 | 000 |
| 00386100001933 | K130080 | 000 |
| 00386100001926 | K130080 | 000 |
| 00386100001919 | K130080 | 000 |
| 00386100001803 | K130080 | 000 |