N Latex Cystatin C; N Protein Standard UY
K-Number: K171072 · 2017-05-12
Decision Date2017-05-12
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
N Latex Cystatin C; N Protein Standard UY is a medical device manufactured by Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2017-05-12 under approval 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. It is manufactured by Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K171072.
When was N Latex Cystatin C; N Protein Standard UY approved by the FDA?
N Latex Cystatin C; N Protein Standard UY received FDA 510(k) clearance on 2017-05-12, under approval number K171072.
What company makes N Latex Cystatin C; N Protein Standard UY?
N Latex Cystatin C; N Protein Standard UY is manufactured by Siemens Healthcare Diagnostics Products GmbH.
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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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.