Cleared Traditional

ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay

K163658 · Siemens Healthcare Diagnostics, Inc. · Chemistry
May 2017
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K163658 is an FDA 510(k) clearance for the ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on May 23, 2017, 151 days after receiving the submission on December 23, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K163658 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2016
Decision Date May 23, 2017
Days to Decision 151 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEW — Radioimmunoassay, Parathyroid Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1545

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