The following data is part of a premarket notification filed by Prognostix, Inc. with the FDA for Cardiompo Test.
| Device ID | K050029 |
| 510k Number | K050029 |
| Device Name: | CARDIOMPO TEST |
| Classification | Myeloperoxidase, Immunoassay, System, Test |
| Applicant | PROGNOSTIX, INC. 10265 CARNEGIE AVENUE Cleveland, OH 44106 |
| Contact | Thomas M Jackson |
| Correspondent | Thomas M Jackson PROGNOSTIX, INC. 10265 CARNEGIE AVENUE Cleveland, OH 44106 |
| Product Code | NTV |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-06 |
| Decision Date | 2005-05-10 |
| Summary: | summary |