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510(k) K001645

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 by Dade Behring, Inc. — Product Code GKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2000
Date Received
May 30, 2000
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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