Cleared Traditional

K981185 - GLU (FDA 510(k) Clearance)

K981185 · Abbott Laboratories · Chemistry device
May 1998
Decision
35d
Days
Class 2
Risk

K981185 is an FDA 510(k) clearance for the GLU. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on May 7, 1998, 35 days after receiving the submission on April 2, 1998.

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

Submission Details

510(k) Number K981185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1998
Decision Date May 07, 1998
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CFR — Hexokinase, Glucose
Device Class Class II - Special Controls
CFR Regulation 21 CFR 862.1345