510(k) K022108

THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 by Thermo Dma, Inc. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2002
Date Received
June 28, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type