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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory (IL) Co.. It received FDA 510(k) clearance on 2026-03-20 under 510(k) 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. The listed applicant is Instrumentation Laboratory (IL) Co.. The 510(k) number is K260551.

When did HemosIL Factor V Leiden (APC Resistance V) receive FDA 510(k) clearance?

HemosIL Factor V Leiden (APC Resistance V) received FDA 510(k) clearance on 2026-03-20, under 510(k) number K260551.

Who is the listed applicant for HemosIL Factor V Leiden (APC Resistance V)?

The FDA 510(k) record lists Instrumentation Laboratory (IL) Co. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Instrumentation Laboratory (IL) Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253957HemosIL Silica Clotting TimeK251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLK243374HemosIL CL HIT-IgG(PF4-H)K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)

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.

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