Cleared Traditional

TOTAL GALACTOSE

K894011 · Alpkem Corp. · Chemistry

Jan 1990

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K894011 is an FDA 510(k) clearance for the TOTAL GALACTOSE, a Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase (Class II — Special Controls, product code KQP), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on January 11, 1990, 219 days after receiving the submission on June 6, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1315.

Submission Details

510(k) Number	K894011 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 1989
Decision Date	January 11, 1990
Days to Decision	219 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	KQP — Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1315