Cleared Traditional

Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)

K161954 · Siemens Healthcare Diagnostics · Chemistry
Mar 2017
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K161954 is an FDA 510(k) clearance for the Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc), a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Siemens Healthcare Diagnostics (New York, US). The FDA issued a Cleared decision on March 9, 2017, 234 days after receiving the submission on July 18, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K161954 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2016
Decision Date March 09, 2017
Days to Decision 234 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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