Cleared Traditional

GSP Neonatal Total Galactose kit

K190335 · Perkinelmer, Inc. · Chemistry
Nov 2019
Decision
265d
Days
Class 1
Risk

About This 510(k) Submission

K190335 is an FDA 510(k) clearance for the GSP Neonatal Total Galactose kit, a Enzymatic Methods, Galactose (Class I — General Controls, product code JIA), submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on November 6, 2019, 265 days after receiving the submission on February 14, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1310.

Submission Details

510(k) Number K190335 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2019
Decision Date November 06, 2019
Days to Decision 265 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIA — Enzymatic Methods, Galactose
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1310

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