Invader Factor V
FDA 510(k) K100980 · Hologic, Inc.
510(k) numberK100980
Submission
- Device name
- Invader Factor V
- Applicant
- Hologic, Inc.
Malborough, MA, US - Received
- April 8, 2010
- Decision date
- June 1, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NPQ – Test, Factor V Leiden Mutations, Genomic Dna Pcr
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7280
- Specialty
- Hematology
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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Questions and answers
When was Invader Factor V cleared by the FDA?
Invader Factor V (K100980) received a 510(k) decision of Substantially Equivalent on June 1, 2011, 419 days after the submission was received.
What is the product code of K100980?
The FDA product code is NPQ – Test, Factor V Leiden Mutations, Genomic Dna Pcr, a Class II (moderate risk) device regulated under 21 CFR 864.7280.