Cleared Traditional

NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT

K950481 · Isolab, Inc. · Chemistry
Feb 1996
Decision
363d
Days
Class 1
Risk

About This 510(k) Submission

K950481 is an FDA 510(k) clearance for the NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT, a Enzymatic Methods, Galactose (Class I — General Controls, product code JIA), submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on February 1, 1996, 363 days after receiving the submission on February 3, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1310.

Submission Details

510(k) Number K950481 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1995
Decision Date February 01, 1996
Days to Decision 363 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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