Cleared Traditional

K971754 - LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
(FDA 510(k) Clearance)

K971754 · Pointe Scientific, Inc., · Chemistry

Jul 1997

Decision

71d

Days

Class 2

Risk

K971754 is an FDA 510(k) clearance for the LIQUID GLUCOSE (HEXOKINASE) REAGENT SET. This device is classified as a Hexokinase, Glucose (Class II — Special Controls, product code CFR).

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on July 22, 1997, 71 days after receiving the submission on May 12, 1997.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K971754 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 1997
Decision Date	July 22, 1997
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement