Cleared Traditional

KING DIAGNOSTICS GLUCOSE (HK) REAGENT

K923129 · King Diagnostics, Inc. · Chemistry
Nov 1992
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K923129 is an FDA 510(k) clearance for the KING DIAGNOSTICS GLUCOSE (HK) REAGENT, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 2, 1992, 129 days after receiving the submission on June 26, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K923129 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1992
Decision Date November 02, 1992
Days to Decision 129 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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