The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Chemtrak Platinum Comprehensive Liquid Assayed Chemistry And Tdm Control Level 1, Model Ap11001, Level 2, Model Ap22002.
| Device ID | K980514 |
| 510k Number | K980514 |
| Device Name: | CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Contact | Scott D Kinghorn |
| Correspondent | Scott D Kinghorn MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-10 |
| Decision Date | 1998-03-04 |