Cleared Traditional

CHOLESTECH L.D.X. SYSTEM

K932727 · Cholestech Corp. · Chemistry
Nov 1993
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K932727 is an FDA 510(k) clearance for the CHOLESTECH L.D.X. SYSTEM, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on November 9, 1993, 158 days after receiving the submission on June 4, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K932727 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 1993
Decision Date November 09, 1993
Days to Decision 158 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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