HemosIL Factor V Leiden (APC Resistance V)
K-Number: K260551 · 2026-03-20
ApplicantInstrumentation Laboratory (IL) Co.
Decision Date2026-03-20
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
HemosIL Factor V Leiden (APC Resistance V) is a medical device manufactured by Instrumentation Laboratory (IL) Co.. It received FDA 510(k) clearance on 2026-03-20 under approval number K260551. The device is classified under product code GGW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HemosIL Factor V Leiden (APC Resistance V)?
HemosIL Factor V Leiden (APC Resistance V) is a medical device that received FDA 510(k) clearance on 2026-03-20. It is manufactured by Instrumentation Laboratory (IL) Co.. The 510(k) number is K260551.
When was HemosIL Factor V Leiden (APC Resistance V) approved by the FDA?
HemosIL Factor V Leiden (APC Resistance V) received FDA 510(k) clearance on 2026-03-20, under approval number K260551.
What company makes HemosIL Factor V Leiden (APC Resistance V)?
HemosIL Factor V Leiden (APC Resistance V) is manufactured by Instrumentation Laboratory (IL) Co..
What is the FDA product code for HemosIL Factor V Leiden (APC Resistance V)?
The FDA product code for HemosIL Factor V Leiden (APC Resistance V) is GGW.
Related Clinical Trials
Other Devices by Instrumentation Laboratory (IL) Co.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.