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510(k) K061014

ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP by Helena Laboratories — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2006
Date Received
April 13, 2006
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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