CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)— 510(k) K032027

Clearance details

Applicant

Cholestech Corp.

Product code

Code CIS

Device class

Class 2

Regulation

21 CFR 862.1100

Advisory panel

Clinical Chemistry

Date received

2003-07-01

Decision date

2003-09-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hayward, CA, US

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• Z-1139-2013 — Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).Class II·Terminated·Alere San Diego, Inc.·20130306

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032027.