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510(k) K841803

A1 SYSTEME 8201/2 by Med USA — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1985
Date Received
May 1, 1984
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

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