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510(k) K070635

HEMOSIL PROCLOT by Instrumentation Laboratory CO — Product Code GGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2007
Date Received
March 7, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Qualitative And Quantitative Factor Deficiency
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type

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  • K181525 — INNOVANCE Free PS Ag (September 7, 2018)
  • K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (March 13, 2014)