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 |