Cleared Traditional

CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)

K032027 · Cholestech Corp. · Chemistry
Sep 2003
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K032027 is an FDA 510(k) clearance for the CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST), a Hydrazone Colorimetry, Ast/sgot (Class II — Special Controls, product code CIS), submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on September 5, 2003, 66 days after receiving the submission on July 1, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K032027 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2003
Decision Date September 05, 2003
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIS — Hydrazone Colorimetry, Ast/sgot
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1100