The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Clinical Chemistry Analyzer.
| Device ID | K070057 |
| 510k Number | K070057 |
| Device Name: | EASYRA CLINICAL CHEMISTRY ANALYZER |
| Classification | Glucose Oxidase, Glucose |
| 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 | CGA |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIH |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-05 |
| Decision Date | 2007-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100004385 | K070057 | 000 |
| 00386100004378 | K070057 | 000 |
| 00386100002282 | K070057 | 000 |