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510(k) K170314

ACL AcuStar by Instrumentation Laboratory CO — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2017
Date Received
February 1, 2017
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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