N Latex FLC kappa, N Latex FLC lambda
K-Number: K193047 · 2021-07-14
Decision Date2021-07-14
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
N Latex FLC kappa, N Latex FLC lambda is a medical device manufactured by Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2021-07-14 under approval number K193047. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the N Latex FLC kappa, N Latex FLC lambda?
N Latex FLC kappa, N Latex FLC lambda is a medical device that received FDA 510(k) clearance on 2021-07-14. It is manufactured by Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K193047.
When was N Latex FLC kappa, N Latex FLC lambda approved by the FDA?
N Latex FLC kappa, N Latex FLC lambda received FDA 510(k) clearance on 2021-07-14, under approval number K193047.
What company makes N Latex FLC kappa, N Latex FLC lambda?
N Latex FLC kappa, N Latex FLC lambda is manufactured by Siemens Healthcare Diagnostics Products GmbH.
What is the FDA product code for N Latex FLC kappa, N Latex FLC lambda?
The FDA product code for N Latex FLC kappa, N Latex FLC lambda is DFH.
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K161312Sysmex Automated Blood Coagulation Analyzer CS-2100i
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K171742N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2
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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.