The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Mas Chemtrak H & Dade Moni-trol H Liquid Assayed Chemistry Control.
| Device ID | K030942 |
| 510k Number | K030942 |
| Device Name: | MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL |
| 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 | 2003-03-26 |
| Decision Date | 2003-04-28 |