HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
K-Number: K251968 · 2025-07-24
ApplicantInstrumentation Laboratory (IL) Co.
Decision Date2025-07-24
Product CodeKQJ
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL is a medical device manufactured by Instrumentation Laboratory (IL) Co.. It received FDA 510(k) clearance on 2025-07-24 under approval number K251968. The device is classified under product code KQJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL?
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL is a medical device that received FDA 510(k) clearance on 2025-07-24. It is manufactured by Instrumentation Laboratory (IL) Co.. The 510(k) number is K251968.
When was HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL approved by the FDA?
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL received FDA 510(k) clearance on 2025-07-24, under approval number K251968.
What company makes HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL?
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL is manufactured by Instrumentation Laboratory (IL) Co..
What is the FDA product code for HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL?
The FDA product code for HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL is KQJ.
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.