Cleared Special

DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE

K083465 · Siemens Healthcare Diagnostics · Chemistry
Feb 2009
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K083465 is an FDA 510(k) clearance for the DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on February 27, 2009, 95 days after receiving the submission on November 24, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K083465 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2008
Decision Date February 27, 2009
Days to Decision 95 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGS — Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

Similar Devices — CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

All 122
Pointe Scientific Creatinine Kinase (CK) Reagent Set
K191296 · Medtest DX · Aug 2020
SEKURE Creatine Kinase Assay
K182702 · Sekisui Diagnostics P.E.I., Inc. · Apr 2019
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator
K160724 · Siemens Healthcare Diagnostics, Inc. · Sep 2016
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
K123977 · Randox Laboratories, Ltd. · Nov 2013
CPK REAGENT
K112416 · Vital Diagnostics (Manufacturing) Ptyltd · Nov 2011
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32
K081731 · Siemens Healthcare Diagnostics · Aug 2008

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