The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Cardioimmune Cardiac Marker Control Levels 1,2, And 3.
| Device ID | K984277 |
| 510k Number | K984277 |
| Device Name: | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Contact | Scot D Kinghorn |
| Correspondent | Scot D Kinghorn MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-30 |
| Decision Date | 1998-12-09 |