Cleared Traditional

CARESIDE ALT

K020487 · Careside, Inc. · Chemistry
Jun 2002
Decision
111d
Days
Class 1
Risk

About This 510(k) Submission

K020487 is an FDA 510(k) clearance for the CARESIDE ALT, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on June 4, 2002, 111 days after receiving the submission on February 13, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K020487 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2002
Decision Date June 04, 2002
Days to Decision 111 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CKA — Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1030

Similar Devices — CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 126
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
K120945 · Hitachi Chemical Diagnostics, Inc. · Jun 2013
ACE ALT REAGENT
K113382 · Alfa Wassermann · Jul 2012
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
K061020 · Dade Behring, Inc. · May 2006
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K980028 · Trace America, Inc. · Feb 1998
TRACE REAGENT LINE FOR THE COBAS MIRA
K973869 · Trace America, Inc. · Jan 1998
ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30
K974003 · Diagnostic Chemicals , Ltd. · Dec 1997