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FDA 510(k)

N Latex FLC kappa, N Latex FLC lambda

K-Number: K193047 · 2021-07-14

ApplicantSiemens Healthcare Diagnostics Products GmbH
Decision Date2021-07-14
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N Latex FLC kappa, N Latex FLC lambda is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2021-07-14 under 510(k) 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. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K193047.

When did N Latex FLC kappa, N Latex FLC lambda receive FDA 510(k) clearance?

N Latex FLC kappa, N Latex FLC lambda received FDA 510(k) clearance on 2021-07-14, under 510(k) number K193047.

Who is the listed applicant for N Latex FLC kappa, N Latex FLC lambda?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.

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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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.

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