The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Cardioimmune Tl Cardiac Marker Control Levels 1, 2, 3, And Multi-pack.
| Device ID | K010111 |
| 510k Number | K010111 |
| Device Name: | CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012 |
| Contact | Darwin Richardson |
| Correspondent | Darwin Richardson MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-12 |
| Decision Date | 2001-02-28 |