Cleared Traditional

COULTER DART AST (GOT) REAGENT

K905771 · Coulter Electronics, Inc. · Chemistry
Feb 1991
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K905771 is an FDA 510(k) clearance for the COULTER DART AST (GOT) REAGENT, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on February 26, 1991, 61 days after receiving the submission on December 27, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K905771 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1990
Decision Date February 26, 1991
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIT — Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1100

Similar Devices — CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 138
AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-
K093883 · Seppim S.A.S. · Sep 2010
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
K080485 · Diasys Diagnostics Systems GmbH · Dec 2008
ACTIVATED ASPARTATE AMINOTRANSFERASE
K071525 · Abbott Laboratories · Mar 2008
AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
K071580 · Thermofisher Scientific OY · Oct 2007
COBAS C 111 ANALYZER
K071211 · Roche Diagnostics · Jul 2007
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060318 · Horiba Abx · Aug 2006