Cleared Traditional

EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR

K080404 · Medica Corp. · Chemistry
Mar 2009
Decision
393d
Days
Class 2
Risk

About This 510(k) Submission

K080404 is an FDA 510(k) clearance for the EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on March 13, 2009, 393 days after receiving the submission on February 14, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K080404 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2008
Decision Date March 13, 2009
Days to Decision 393 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

Similar Devices — JIX Calibrator, Multi-analyte Mixture

All 301
VITROS Chemistry Products Calibrator Kit 3
K161140 · Ortho-Clinical Diagnostics, Inc. · May 2016
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
K153365 · Siemens Healthcare Diagnostics, Inc. · Dec 2015
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
K151552 · Elitechgroup · Jul 2015
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
K140790 · Siemens Healthcare Diagnostics · Jun 2015
SYSTEM CALIBRATER
K141388 · Beckman Coulter Ireland, Inc. · Jul 2014
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
K133330 · Roche Diagnostics · Nov 2013