510(k) K871830

NAPSAC(TM) by Beecher Medical Diagnostic Instrumentation — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1987
Date Received
May 11, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Cell, Automated (Particle Counter)
Device Class
Class II
Regulation Number
864.5200
Review Panel
HE
Submission Type