The following data is part of a premarket notification filed by Medica Corp. with the FDA for Ppx Reagent, Ppx Calibrators, Ppx Qc Material.
| Device ID | K111363 |
| 510k Number | K111363 |
| Device Name: | PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL |
| Classification | Enzyme Immunoassay, Propoxyphene |
| 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 | JXN |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-16 |
| Decision Date | 2011-12-06 |