HemosIL Chromogenic Factor IX
K-Number: K230852 · 2023-12-13
ApplicantInstrumentation Laboratory Company
Decision Date2023-12-13
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
HemosIL Chromogenic Factor IX is a medical device manufactured by Instrumentation Laboratory Company. It received FDA 510(k) clearance on 2023-12-13 under approval number K230852. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HemosIL Chromogenic Factor IX?
HemosIL Chromogenic Factor IX is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Instrumentation Laboratory Company. The 510(k) number is K230852.
When was HemosIL Chromogenic Factor IX approved by the FDA?
HemosIL Chromogenic Factor IX received FDA 510(k) clearance on 2023-12-13, under approval number K230852.
What company makes HemosIL Chromogenic Factor IX?
HemosIL Chromogenic Factor IX is manufactured by Instrumentation Laboratory Company.
What is the FDA product code for HemosIL Chromogenic Factor IX?
The FDA product code for HemosIL Chromogenic Factor IX is GGP.
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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.