510(k) K851450

FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM by Flow Cytometry Standards Corp. — Product Code JIW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1985
Date Received
April 11, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Surrogate
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type