510(k) K013654

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER by Precision Systems, Inc. — Product Code JJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2002
Date Received
November 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Micro, For Clinical Use
Device Class
Class I
Regulation Number
862.2170
Review Panel
CH
Submission Type