Cleared Traditional

K980026 - GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
(FDA 510(k) Clearance)

K980026 · Trace America, Inc. · Chemistry

Mar 1998

Decision

64d

Days

Class 2

Risk

K980026 is an FDA 510(k) clearance for the GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST). This device is classified as a Hexokinase, Glucose (Class II — Special Controls, product code CFR).

Submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on March 10, 1998, 64 days after receiving the submission on January 5, 1998.

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

Submission Details

510(k) Number	K980026 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 1998
Decision Date	March 10, 1998
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement