HemosIL D-Dimer HS 500
K-Number: K172903 · 2017-11-22
ApplicantInstrumentation Laboratory CO
Decision Date2017-11-22
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
HemosIL D-Dimer HS 500 is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2017-11-22 under approval number K172903. 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 500?
HemosIL D-Dimer HS 500 is a medical device that received FDA 510(k) clearance on 2017-11-22. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K172903.
When was HemosIL D-Dimer HS 500 approved by the FDA?
HemosIL D-Dimer HS 500 received FDA 510(k) clearance on 2017-11-22, under approval number K172903.
What company makes HemosIL D-Dimer HS 500?
HemosIL D-Dimer HS 500 is manufactured by Instrumentation Laboratory CO.
What is the FDA product code for HemosIL D-Dimer HS 500?
The FDA product code for HemosIL D-Dimer HS 500 is DAP.
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K160885HemosIL D-Dimer HS
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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.