HemosIL Liquid Anti-Xa
K-Number: K223187 · 2023-06-23
ApplicantInstrumentation Laboratory CO
Decision Date2023-06-23
Product CodeQLU
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 2023-06-23 under approval number K223187. The device is classified under product code QLU. 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 2023-06-23. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K223187.
When was HemosIL Liquid Anti-Xa approved by the FDA?
HemosIL Liquid Anti-Xa received FDA 510(k) clearance on 2023-06-23, under approval number K223187.
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 QLU.
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K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
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Related Devices (Code: QLU)
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.