The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyqc - Chemistry With Electrolytes; Chemistry; Electrolytes Kit; Chemistry Calibrator, Crea-u Claibrator.
| Device ID | K080404 |
| 510k Number | K080404 |
| Device Name: | EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJR |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-14 |
| Decision Date | 2009-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100001889 | K080404 | 000 |
| 00386100001872 | K080404 | 000 |
| 00386100001735 | K080404 | 000 |