Cleared Traditional

DIMENSION CHEMISTRY III CALIBRATORY

K123321 · Siemens Healthcare Diagnostics · Chemistry
Feb 2013
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K123321 is an FDA 510(k) clearance for the DIMENSION CHEMISTRY III CALIBRATORY, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on February 15, 2013, 112 days after receiving the submission on October 26, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K123321 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2012
Decision Date February 15, 2013
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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

More from Siemens Healthcare Diagnostics

View all
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
K243570 · JLW · Apr 2025
ADVIA 2120i, ADVIA 2120
K162977 · GKZ · Aug 2017
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
K162298 · MRG · Mar 2017
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
K161954 · JGS · Mar 2017
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
K162538 · JIT · Nov 2016