Cleared Traditional

ACTIVATED ASPARTATE AMINOTRANSFERASE

K071525 · Abbott Laboratories · Chemistry
Mar 2008
Decision
289d
Days
Class 2
Risk

About This 510(k) Submission

K071525 is an FDA 510(k) clearance for the ACTIVATED ASPARTATE AMINOTRANSFERASE, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on March 19, 2008, 289 days after receiving the submission on June 4, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K071525 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2007
Decision Date March 19, 2008
Days to Decision 289 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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
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
WIENER LAB GOT (AST) UV AA LIQUIDA
K023551 · Wiener Laboratories Saic · Dec 2002