Cleared Traditional

N Latex Cystatin C; N Protein Standard UY

K171072 · Siemens Healthcare Diagnostics Products GmbH · Chemistry
May 2017
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K171072 is an FDA 510(k) clearance for the N Latex Cystatin C; N Protein Standard UY, a Test, Cystatin C (Class II — Special Controls, product code NDY), submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on May 12, 2017, 32 days after receiving the submission on April 10, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K171072 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2017
Decision Date May 12, 2017
Days to Decision 32 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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