Cleared Traditional

LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers

K150879 · DiaSorin, Inc. · Chemistry
Jun 2015
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K150879 is an FDA 510(k) clearance for the LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on June 22, 2015, 82 days after receiving the submission on April 1, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K150879 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2015
Decision Date June 22, 2015
Days to Decision 82 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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