HemosIL Silica Clotting Time
K-Number: K253957 · 2026-01-09
ApplicantInstrumentation Laboratory (IL) Co.
Decision Date2026-01-09
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
HemosIL Silica Clotting Time is a medical device manufactured by Instrumentation Laboratory (IL) Co.. It received FDA 510(k) clearance on 2026-01-09 under approval number K253957. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HemosIL Silica Clotting Time?
HemosIL Silica Clotting Time is a medical device that received FDA 510(k) clearance on 2026-01-09. It is manufactured by Instrumentation Laboratory (IL) Co.. The 510(k) number is K253957.
When was HemosIL Silica Clotting Time approved by the FDA?
HemosIL Silica Clotting Time received FDA 510(k) clearance on 2026-01-09, under approval number K253957.
What company makes HemosIL Silica Clotting Time?
HemosIL Silica Clotting Time is manufactured by Instrumentation Laboratory (IL) Co..
What is the FDA product code for HemosIL Silica Clotting Time?
The FDA product code for HemosIL Silica Clotting Time is GFO.
Other Devices by Instrumentation Laboratory (IL) Co.
Related Devices (Code: GFO)
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.