FDA.reportPublic FDA data

SelectaLyte (Potassium Electrode)

Primary DI
00850229007331
Brand
SelectaLyte (Potassium Electrode)
Company
AWARENESS TECHNOLOGY, INCORPORATED
Model
3910
Published
2019-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CEMElectrode, Ion Specific, Potassium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171476000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171476000SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)Awareness Technology, Inc.2018-02-27JGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850229007331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850229007331008502290073318502290073310850229007331

GMDN Terms#

Term, Definition table
TermDefinition
Multiple electrolyte IVD, kit, ion-selective electrode (ISE)A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen, using an ion-selective electrode (ISE) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071065130
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850229007089StatFax 22002023-06-05
00850229007010StatFax47002023-06-05
00850229007027StatFax45002023-06-05
00850229007034StatFax42002023-06-05
00850229007041StatFax33002023-06-05
00850229007072StatFax26002023-06-05
00850229007102StatFax1904+2023-06-05
00850229007126LumiStat49002023-06-05
00850229007140LuMate44002023-06-05
00850229007201ChroMate43002023-06-05
00850229007218ChemWell-T46202023-06-05
00850229007232ChemWell29102023-06-05
00850229007461ChemWell251002023-06-05
00850229007119Redi-Check Photometer QCRedi-Check Photometer QCE3052016-06-30
00850229007164DriDye 492492E002-4922016-06-30
00850229007171DriDye 450450E002-4502016-06-30
00850229007188DriDye 405/ 450405/ 4502016-06-30
00850229007195DriDye 405405E002-4052016-06-30
00850229007225ChemWell® FUSION480048002022-03-03
00850229007287SelectaLyte39102019-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740215712AlinityABBOTT LABORATORIESCEM2025-10-08
10054749005519i-STATABBOTT POINT OF CARE INC.CEM2020-05-01
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.CEM2020-04-15
00380740156855ARCHITECTABBOTT LABORATORIESCEM2019-10-31
00380740163372ARCHITECTAbbott GmbHCEM2019-08-15
00386100002282ISE Reagent PackMEDICA CORPORATIONCEM2019-02-14
00386100004378EasyRA Analyzer (LIS)MEDICA CORPORATIONCEM2019-02-14
00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONCEM2019-02-14
00386100001650ISE Disposable Reference Electrode MEDICA CORPORATIONCEM2018-12-11
00386100002503Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-11
00386100002541EasyElectrolyte Reagent Module, Na/K/Cl AnalyzersMEDICA CORPORATIONCEM2018-12-11
00386100002558EasyElectrolyte Reagent Module, Na/K/Li AnalyzersMEDICA CORPORATIONCEM2018-12-11
00386100002794ISE Cleaning Solution KitMEDICA CORPORATIONCEM2018-12-11
00386100002817ISE Reagent PackMEDICA CORPORATIONCEM2018-12-11
00386100002831ISE Reagent ModuleMEDICA CORPORATIONCEM2018-12-11
00386100003524Na/K/Li AnalyzerMEDICA CORPORATIONCEM2018-12-11
00386100002596pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100002633Bi-Level QC Kit, HCTMEDICA CORPORATIONCEM2018-12-05
00386100002664Reagent ModuleMEDICA CORPORATIONCEM2018-12-05
00386100003630pH/pCO2/pO2/Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100003739pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONCEM2018-12-05
00386100002879Na/K/Cl AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002886Lithium Na/K/Li AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002893Calcium Na/K/Ca/pH AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002909Na/K/Cl/Li AnalyzerMEDICA CORPORATIONCEM2018-12-04
00386100002916Na/K/Cl/Li Solution Pack MEDICA CORPORATIONCEM2018-12-04
00386100002923Na/K/Cl/Li Solution PackMEDICA CORPORATIONCEM2018-12-04
00386100003043Na/K/Cl Solution PackMEDICA CORPORATIONCEM2018-12-04
00386100003067Na/K/Ca/pH Solution Pack MEDICA CORPORATIONCEM2018-12-04
00386100003074Na/K/Li Solution PackMEDICA CORPORATIONCEM2018-12-04