Cleared Traditional

NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B

K071649 · Wallac OY · Chemistry
Aug 2008
Decision
416d
Days
Class 1
Risk

About This 510(k) Submission

K071649 is an FDA 510(k) clearance for the NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B, a Enzymatic Methods, Galactose (Class I — General Controls, product code JIA), submitted by Wallac OY (Waltham, US). The FDA issued a Cleared decision on August 7, 2008, 416 days after receiving the submission on June 18, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1310.

Submission Details

510(k) Number K071649 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2007
Decision Date August 07, 2008
Days to Decision 416 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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