Cleared Traditional

Lumipulse G whole PTH

K190702 · Fujirebio Diagnostics,Inc. · Chemistry
Aug 2019
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K190702 is an FDA 510(k) clearance for the Lumipulse G whole PTH, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on August 30, 2019, 165 days after receiving the submission on March 18, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K190702 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2019
Decision Date August 30, 2019
Days to Decision 165 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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