HemosIL Silica Clotting Time
K-Number: K160445 · 2016-03-16
ApplicantInstrumentation Laboratory CO
Decision Date2016-03-16
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
HemosIL Silica Clotting Time is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2016-03-16 under approval number K160445. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HemosIL Silica Clotting Time?
HemosIL Silica Clotting Time is a medical device that received FDA 510(k) clearance on 2016-03-16. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K160445.
When was HemosIL Silica Clotting Time approved by the FDA?
HemosIL Silica Clotting Time received FDA 510(k) clearance on 2016-03-16, under approval number K160445.
What company makes HemosIL Silica Clotting Time?
HemosIL Silica Clotting Time is manufactured by Instrumentation Laboratory CO.
What is the FDA product code for HemosIL Silica Clotting Time?
The FDA product code for HemosIL Silica Clotting Time is GFO.
Other Devices by Instrumentation Laboratory CO
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K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
K160885HemosIL D-Dimer HS
K161818GEM Premier 3000
Related Devices (Code: GFO)
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.