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510(k) K930685

TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) by Heraeus Kulzer, Inc. — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1993
Date Received
February 10, 1993
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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