FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K993211 |
ABAXIS, INC. |
PICCOLO SODIUM TEST SYSTEM |
10/25/1999 |
K213486 |
Abbott Laboratories |
GLP systems Track |
03/10/2022 |
K153357 |
ABBOTT POINT OF CARE INC. |
i-STAT Alinity System with i-STAT Sodium test |
07/08/2016 |
K183688 |
Abbott Point of Care, Inc. |
i-STAT CHEM8+ cartridge with the i-STAT 1 System |
02/07/2020 |
K172232 |
AMS Diagnostics |
LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 |
06/12/2019 |
K171476 |
Awareness Technology, Inc. |
SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) |
02/27/2018 |
K990346 |
BAYER CORP. |
BAYER ADVIA 1650 CHEMISTRY SYSTEM |
05/21/1999 |
K161837 |
BECKMAN COULTER INC. |
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer |
12/16/2016 |
K220977 |
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. |
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer |
07/20/2023 |
K011213 |
BECKMAN COULTER, INC. |
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM |
05/16/2001 |
K023049 |
BECKMAN COULTER, INC. |
SYNCHRON LX I 725 CLINICAL SYSTEM |
10/04/2002 |
K002855 |
BIOCARE CORP. |
BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER |
10/12/2000 |
K990036 |
CARESIDE, INC. |
CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 |
03/18/1999 |
K121140 |
DIAMOND DIAGNOSTICS, INC |
PROLYTE ELECTROLYTE ANALYZER |
08/22/2012 |
K082462 |
DIAMOND DIAGNOSTICS, INC. |
GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ |
02/06/2009 |
K070104 |
DIAMOND DIAGNOSTICS, INC. |
PROLYTE ELECTROLYTE ANALYZER |
05/07/2008 |
K102959 |
DIAMOND DIAGNOSTICS, INC. |
PROLYTE ELECTROLYTE ANALYZER |
01/14/2011 |
K992844 |
ELAN HOLDINGS, INC. |
HICHEM ISE ELECTROLYTE BUFFER |
11/26/1999 |
K992842 |
ELAN HOLDINGS, INC. |
HICHEM ISE ELECTROLYTE REFERENCE |
11/26/1999 |
K102647 |
ELITECHGROUP VITAL SCIENTIFIC BV |
ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... |
03/24/2011 |
K061597 |
EPOCAL, INC. |
EPOC BLOOD ANALYSIS SYSTEM |
09/27/2006 |
K040977 |
GENCHEM, INC. |
GENCHEM ELECTROLYTE BUFFER |
12/27/2004 |
K040971 |
GENCHEM, INC. |
GENCHEM ISE ELECTROLYTE REFERENCE |
12/22/2004 |
K001154 |
I-STAT CORP. |
I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER |
04/18/2000 |
K053110 |
I-STAT CORPORATION |
I-STAT CHEM8 + CARTRIDGE |
01/13/2006 |
K181201 |
Infrared Laboratory Systems, LLC (dba Synermed) |
Synermed ISE Reagents |
07/10/2018 |
K160225 |
INSTRUMENTATION LABORATORY CO. |
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator |
12/14/2016 |
K183549 |
Instrumentation Laboratory Co. |
GEM Premier ChemSTAT |
02/16/2019 |
K961099 |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+) |
05/07/1996 |
K002407 |
MEDICA CORP. |
EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER |
02/02/2001 |
K100673 |
MEDICA CORP. |
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 |
04/06/2010 |
K963763 |
MEDICA CORP. |
EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER |
11/29/1996 |
K100829 |
MEDICA CORP. |
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520 |
01/14/2011 |
K955375 |
MEDICA CORP. |
EASYSTAT SODIUM/POTASSIUM ANALYZER |
02/23/1996 |
K955374 |
MEDICA CORP. |
EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER |
02/23/1996 |
K000895 |
NOVA BIOMEDICAL CORP. |
STAT PROFILE PHOX PLUS ANALYZER |
04/17/2000 |
K001761 |
NOVA BIOMEDICAL CORP. |
STATLYTE NA/K/CL/LI ANALYZER |
08/07/2000 |
K191365 |
Nova Biomedical Corporation |
Stat Profile Prime ES Comp Plus Analyzer System |
07/19/2019 |
K180428 |
Nova Biomedical Corporation |
Stat Profile Prime Plus Analyzer System |
08/15/2018 |
K200403 |
Nova Biomedical Corporation |
Stat Profile Prime Plus Analyzer System |
04/14/2020 |
K081411 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 |
06/30/2008 |
K091861 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 |
09/03/2009 |
K020364 |
PHOENIX DIAGNOSTICS, INC. |
PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS |
06/04/2002 |
K051646 |
POINTE SCIENTIFIC, INC. |
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH |
10/07/2005 |
K962334 |
RADIOMETER AMERICA, INC. |
EML105 ELECTROLYTE METABOLITE ANALYZER |
10/24/1996 |
K963627 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE |
10/24/1996 |
K123726 |
Roche Diagnostics |
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 |
05/21/2013 |
K132418 |
Roche Diagnostics |
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 |
12/18/2013 |
K140373 |
Roche Diagnostics |
ISE INDIRECT NA, K, C1 FOR GEN 2 |
05/22/2014 |
K053165 |
ROCHE DIAGNOSTICS CORP. |
ISE INDIRECT NA, K, CL FOR GEN.2 |
12/14/2005 |
K160370 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer |
06/09/2016 |
K161954 |
Siemens Healthcare Diagnostics |
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) |
03/09/2017 |
K222438 |
Siemens Healthcare Diagnostics Inc. |
A-LYTE« Integrated Multisensor (IMT Na K Cl) |
07/25/2023 |
K151767 |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator |
12/11/2015 |
K963542 |
SIGMA DIAGNOSTICS, INC. |
SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT |
09/27/1996 |
K052724 |
TECO DIAGNOSTICS |
TECO ISE REAGENT SET FOR CX SYSTEM |
12/14/2005 |