The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Mas Cardioimmune Tl Low Level Liquid Assayed Cardiac Marker Control, Dade Cardiac Tl Low Level Liquid Assayed Cardiac Ma.
| Device ID | K023669 |
| 510k Number | K023669 |
| Device Name: | MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012 |
| Contact | Penny M Layman |
| Correspondent | Penny M Layman 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 | 2002-10-31 |
| Decision Date | 2002-12-19 |