Cleared Traditional

ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL

K991498 · Neometrics, Inc. · Chemistry
Jun 1999
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K991498 is an FDA 510(k) clearance for the ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL, a Enzymatic Methods, Galactose (Class I — General Controls, product code JIA), submitted by Neometrics, Inc. (E. Northport, US). The FDA issued a Cleared decision on June 16, 1999, 48 days after receiving the submission on April 29, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1310.

Submission Details

510(k) Number K991498 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 1999
Decision Date June 16, 1999
Days to Decision 48 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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