The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Bilirubin Direct And Total Reagent, Phosphorus Inorganic Reagent And Iron And Magnesium Reagent.
| Device ID | K080810 |
| 510k Number | K080810 |
| Device Name: | EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| Subsequent Product Code | CEO |
| Subsequent Product Code | JGJ |
| Subsequent Product Code | JIY |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-21 |
| Decision Date | 2008-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100002190 | K080810 | 000 |
| 00386100002176 | K080810 | 000 |
| 00386100002169 | K080810 | 000 |
| 00386100002084 | K080810 | 000 |
| 00386100002039 | K080810 | 000 |