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FDA 510(k)

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)

K-Number: K181082 · 2018-05-25

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2018-05-25
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-05-25 under approval number K181082. 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 ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)?

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) is a medical device that received FDA 510(k) clearance on 2018-05-25. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K181082.

When was ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) approved by the FDA?

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) received FDA 510(k) clearance on 2018-05-25, under approval number K181082.

What company makes ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)?

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)?

The FDA product code for ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) 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.

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