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510(k) K082675

STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER by Diagnostica Stago, Inc. — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2008
Date Received
September 15, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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