Cleared Traditional

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)

K181082 · Siemens Healthcare Diagnostics, Inc. · Chemistry
May 2018
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K181082 is an FDA 510(k) clearance for the ADVIA Chemistry Cystatin C_2 Assay (CYSC_2), a Test, Cystatin C (Class II — Special Controls, product code NDY), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on May 25, 2018, 31 days after receiving the submission on April 24, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K181082 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2018
Decision Date May 25, 2018
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NDY — Test, Cystatin C
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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