CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772— 510(k) K991834

Name: FDA 510(k) clearance K991834
Creator: U.S. Food and Drug Administration
Published: 1999-09-09

Substantially Equivalent

Cholestech Corp.

FDA 510(k) clearance K991834 for CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772, Substantially Equivalent on 1999-09-09. Applicant: Cholestech Corp.. Device class: 1.

Clearance details

Applicant: Cholestech Corp.
Product code: Code CKD
Device class: Class 1
Regulation: 21 CFR 862.1030
Advisory panel: Clinical Chemistry
Date received: 1999-05-28
Decision date: 1999-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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K883387 — ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)1988-10-13
K864082 — REFLOTRON(R) ALT (GPT)1986-12-04

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K972012 — CHOLESTECH BUN/CREATININE TEST SYSTEM1997-07-24
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Recalls naming K991834

K-number listed on FDA's recall record

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 K991834.

Data sourced from openFDA. This site is unofficial and independent of the FDA.