The following data is part of a premarket notification filed by Compass Bioscience with the FDA for Cardiac Markers Control And Calibration Verification Control Set.
| Device ID | K062593 |
| 510k Number | K062593 |
| Device Name: | CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | COMPASS BIOSCIENCE 1850 EVERGREEN ST. Duarte, CA 91010 -2906 |
| Contact | Carter Grandjean |
| Correspondent | Carter Grandjean COMPASS BIOSCIENCE 1850 EVERGREEN ST. Duarte, CA 91010 -2906 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-01 |
| Decision Date | 2006-11-22 |
| Summary: | summary |