Cleared Traditional

ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY

K121981 · Siemens Healthcare Diagnostics · Chemistry
Mar 2013
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K121981 is an FDA 510(k) clearance for the ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Siemens Healthcare Diagnostics (New York, US). The FDA issued a Cleared decision on March 21, 2013, 258 days after receiving the submission on July 6, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K121981 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2012
Decision Date March 21, 2013
Days to Decision 258 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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