HemosIL Factor V Leiden (APC Resistance V)— 510(k) K260551

Name: FDA 510(k) clearance K260551
Creator: U.S. Food and Drug Administration
Published: 2026-03-20

Substantially Equivalent

Instrumentation Laboratory (IL) Co.

FDA 510(k) clearance K260551 for HemosIL Factor V Leiden (APC Resistance V), Substantially Equivalent on 2026-03-20. Applicant: Instrumentation Laboratory (IL) Co.. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory (IL) Co.
Product code: Code GGW
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 2026-02-18
Decision date: 2026-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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K090105 — LUPOTEK KCT2010-12-30
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K060284 — CRYOCHECK CLOT APCR2006-05-10
K042762 — PEFAKIT APC-R FACTOR V LEIDEN2004-12-22
K033471 — PHOSPHOLIN ES AND CALCIUM CHLORIDE2004-02-04

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