HemosIL Liquid Anti-Xa
K-Number: K213464 · 2022-10-04
ApplicantInstrumentation Laboratory CO
Decision Date2022-10-04
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
HemosIL Liquid Anti-Xa is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2022-10-04 under approval number K213464. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HemosIL Liquid Anti-Xa?
HemosIL Liquid Anti-Xa is a medical device that received FDA 510(k) clearance on 2022-10-04. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K213464.
When was HemosIL Liquid Anti-Xa approved by the FDA?
HemosIL Liquid Anti-Xa received FDA 510(k) clearance on 2022-10-04, under approval number K213464.
What company makes HemosIL Liquid Anti-Xa?
HemosIL Liquid Anti-Xa is manufactured by Instrumentation Laboratory CO.
What is the FDA product code for HemosIL Liquid Anti-Xa?
The FDA product code for HemosIL Liquid Anti-Xa is KFF.
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Related Devices (Code: KFF)
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.