Cleared Traditional

COULTER ALT (GPT) REAGENT

K897163 · Coulter Electronics, Inc. · Chemistry
Mar 1990
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K897163 is an FDA 510(k) clearance for the COULTER ALT (GPT) REAGENT, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on March 9, 1990, 71 days after receiving the submission on December 28, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K897163 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1989
Decision Date March 09, 1990
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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
CARESIDE ALT
K020487 · Careside, Inc. · Jun 2002
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