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510(k) K100980

INVADER FACTOR V by Hologic, Inc. — Product Code NPQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2011
Date Received
April 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Factor V Leiden Mutations, Genomic Dna Pcr
Device Class
Class II
Regulation Number
864.7280
Review Panel
PA
Submission Type

In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

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Other clearances for product code NPQ

  • K093129 — ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II (April 28, 2010)
  • K093974 — ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII G (April 22, 2010)
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  • DEN030005 — FACTOR V LEIDEN KIT (December 17, 2003)