HemosIL D-Dimer HS
K-Number: K160885 · 2016-10-27
ApplicantInstrumentation Laboratory CO
Decision Date2016-10-27
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
HemosIL D-Dimer HS is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2016-10-27 under approval number K160885. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HemosIL D-Dimer HS?
HemosIL D-Dimer HS is a medical device that received FDA 510(k) clearance on 2016-10-27. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K160885.
When was HemosIL D-Dimer HS approved by the FDA?
HemosIL D-Dimer HS received FDA 510(k) clearance on 2016-10-27, under approval number K160885.
What company makes HemosIL D-Dimer HS?
HemosIL D-Dimer HS is manufactured by Instrumentation Laboratory CO.
What is the FDA product code for HemosIL D-Dimer HS?
The FDA product code for HemosIL D-Dimer HS is DAP.
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)
K161818GEM Premier 3000
K153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
Related Devices (Code: DAP)
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.