The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Mas Cardioimmune Tl Liquid Assayed Cardiac Marker Control, Levels 1,2 And 3.
| Device ID | K040880 |
| 510k Number | K040880 |
| Device Name: | MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 |
| 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 | 2004-04-05 |
| Decision Date | 2004-04-28 |