Cleared Traditional

GSP INSTRUMENT AND GSP NEONATAL HTSH KIT

K090846 · Perkinelmer, Inc. · Chemistry
Sep 2009
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K090846 is an FDA 510(k) clearance for the GSP INSTRUMENT AND GSP NEONATAL HTSH KIT, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Perkinelmer, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 3, 2009, 157 days after receiving the submission on March 30, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K090846 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2009
Decision Date September 03, 2009
Days to Decision 157 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JLW — Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1690

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