HemosIL Factor XII Deficient Plasma
K-Number: K180486 · 2018-03-22
ApplicantInstrumentation Laboratory CO
Decision Date2018-03-22
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
HemosIL Factor XII Deficient Plasma is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2018-03-22 under approval number K180486. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HemosIL Factor XII Deficient Plasma?
HemosIL Factor XII Deficient Plasma is a medical device that received FDA 510(k) clearance on 2018-03-22. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K180486.
When was HemosIL Factor XII Deficient Plasma approved by the FDA?
HemosIL Factor XII Deficient Plasma received FDA 510(k) clearance on 2018-03-22, under approval number K180486.
What company makes HemosIL Factor XII Deficient Plasma?
HemosIL Factor XII Deficient Plasma is manufactured by Instrumentation Laboratory CO.
What is the FDA product code for HemosIL Factor XII Deficient Plasma?
The FDA product code for HemosIL Factor XII Deficient Plasma is GJT.
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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.