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FDA 510(k)

N Latex Cystatin C; N Protein Standard UY

K-Number: K171072 · 2017-05-12

ApplicantSiemens Healthcare Diagnostics Products GmbH
Decision Date2017-05-12
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

N Latex Cystatin C; N Protein Standard UY 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 2017-05-12 under 510(k) number K171072. The device is classified under product code NDY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N Latex Cystatin C; N Protein Standard UY?

N Latex Cystatin C; N Protein Standard UY is a medical device that received FDA 510(k) clearance on 2017-05-12. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K171072.

When did N Latex Cystatin C; N Protein Standard UY receive FDA 510(k) clearance?

N Latex Cystatin C; N Protein Standard UY received FDA 510(k) clearance on 2017-05-12, under 510(k) number K171072.

Who is the listed applicant for N Latex Cystatin C; N Protein Standard UY?

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 Cystatin C; N Protein Standard UY?

The FDA product code for N Latex Cystatin C; N Protein Standard UY is NDY.

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Related Devices (Code: NDY)

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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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