The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Hbalc Regent Easycal Hblc Calibrator Easyqc Hbalc Material.
| Device ID | K120497 |
| 510k Number | K120497 |
| Device Name: | EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL |
| Classification | Assay, Glycosylated Hemoglobin |
| 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 | LCP |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-21 |
| Decision Date | 2012-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100002268 | K120497 | 000 |
| 00386100001902 | K120497 | 000 |
| 00386100001896 | K120497 | 000 |
| 00386100001797 | K120497 | 000 |