The following data is part of a premarket notification filed by Biocentrex with the FDA for Biocentrex Cardiac Panel.
| Device ID | K033155 |
| 510k Number | K033155 |
| Device Name: | BIOCENTREX CARDIAC PANEL |
| Classification | Biosensor, Immunoassay, Cpk Or Isoenzymes |
| Applicant | BIOCENTREX 6100 BRISTOL PARKWAY Culver City, CA 90230 |
| Contact | Thomas H Grove |
| Correspondent | Thomas H Grove BIOCENTREX 6100 BRISTOL PARKWAY Culver City, CA 90230 |
| Product Code | MYT |
| Subsequent Product Code | DDR |
| Subsequent Product Code | JHX |
| Subsequent Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2004-01-12 |
| Summary: | summary |