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510(k) K993174

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 by Dade Behring, Inc. — Product Code GKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1999
Date Received
September 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Coagulation, Automated
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

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