Cleared Traditional

K960084 - HICHEM GLUCOSE/HK REAGENT KIT
(FDA 510(k) Clearance)

K960084 · Hi Chem, Inc. · Chemistry

Apr 1996

Decision

84d

Days

Class 2

Risk

K960084 is an FDA 510(k) clearance for the HICHEM GLUCOSE/HK REAGENT KIT. This device is classified as a Hexokinase, Glucose (Class II — Special Controls, product code CFR).

Submitted by Hi Chem, Inc. (Brea, US). The FDA issued a Cleared decision on April 4, 1996, 84 days after receiving the submission on January 11, 1996.

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

Submission Details

510(k) Number	K960084 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 1996
Decision Date	April 04, 1996
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF