JFP

Product Code: JFP


Products Classified as JFP

387Electrode, Ion Specific, CalciumCalcium Test System.

Total Product Life Cycle (TPLC) Devices

387Electrode, Ion Specific, CalciumCalcium Test System.

FDA Consensus Standards

Electrode, Ion Specific, Calcium [11559]21 CFR §862.1145 🔎
Electrode, Ion Specific, Calcium [11552]21 CFR §862.1145 🔎

Pre-market Notifications for JFP

K191626Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical Corporation
K191360I-STAT CHEM8+ Cartridge With The I-STAT 1 SystemAbbott Point Of Care, Inc.
K152327EasyLyte Na/K/Cl/Ca AnalyzerMedica Corporation
K984299AVL OPTI CRITICAL CARE ANALYZERAVL SCIENTIFIC CORP.
K972673AVL 9181 ELECTROLYTE ANALYZERAVL SCIENTIFIC CORP.
K963694EASYLYTE CALCIUM/CHLORIDE ANALYZERMEDICA CORP.
K961458AVL 9180 ELECTROLYTE ANALYZERAVL SCIENTIFIC CORP.
K960120STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERSNOVA BIOMEDICAL CORP.
K943702AVL 988-4 ELECTROLYTE ANALYZERAVL SCIENTIFIC CORP.
K943091EASY LYTE CALCIUM ANALYZERMEDICA CORP.
K934642I-STAT IONIZED CALCIUM TESTI-STAT CORP.
K915675ELECTRODE, ION SPECIFICALKO DIAGNOSTIC CORP.
K904726LYTENING TM 6/RAMDEV, INC.
K895397CALCIUM AND PH ELECTROLYTE ANALYZERIONETICS, INC.
K884771IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALYINSTRUMENTATION LABORATORY CO.

Global Unique Device Identification Database

00386100003739Electrode, Ion Specific, Calcium
00386100003159Electrode, Ion Specific, Calcium
00386100003135Electrode, Ion Specific, Calcium
00386100003128Electrode, Ion Specific, Calcium
00386100002930Electrode, Ion Specific, Calcium
00386100002664Electrode, Ion Specific, Calcium
00386100002633Electrode, Ion Specific, Calcium
00386100002602Electrode, Ion Specific, Calcium
00386100002596Electrode, Ion Specific, Calcium
10385480539637ELECTRODE, ION SPECIFIC, CALCIUM
00385480528573ELECTRODE, ION SPECIFIC, CALCIUM
00385480489553ELECTRODE, ION SPECIFIC, CALCIUM
00385480485814ELECTRODE, ION SPECIFIC, CALCIUM
10385480420331ELECTRODE, ION SPECIFIC, CALCIUM
10385480420140ELECTRODE, ION SPECIFIC, CALCIUM

Maude Adverse Events

ROCHE 9180 ELECTROLYTE ANALYZERROCHE DIAGNOSTICS2020-03-10
ROCHE 9180 ELECTROLYTE ANALYZERROCHE DIAGNOSTICS2020-02-14
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP.2019-09-04
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2019-09-04
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP.2019-09-04
STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP.2019-09-04
ABL800 FLEXRADIOMETER MEDICAL APS2019-06-28
ROCHE 9180 ELECTROLYTE ANALYZERROCHE DIAGNOSTICS2019-05-17
ROCHE 9180 ELECTROLYTE ANALYZERROCHE DIAGNOSTICS2018-10-17
ROCHE 9180 ELECTROLYTE ANALYZERROCHE DIAGNOSTICS2018-09-14
ROCHE 9180 ELECTROLYTE ANALYZERROCHE DIAGNOSTICS2018-08-06
ROCHE 9180 ELECTROLYTE ANALYZERROCHE DIAGNOSTICS2018-06-05
AVL CALCIUM ELECTRODEROCHE DIAGNOSTICS2018-03-13
ISE 9180ROCHE DIAGNOSTICS2017-03-30
ISE 9180ROCHE DIAGNOSTICS2017-02-16
ANALYTICAL P MODULEROCHE DIAGNOSTICS2015-08-20
COBAS 501EROCHE DIAGNOSTICS GMBH2015-05-12
COBAS 501EROCHE DIAGNOSTICS GMBH2015-05-12
ISE 9180ROCHE DIAGNOSTICS2015-05-04
ISE 9180ROCHE DIAGNOSTICS2015-01-06
ISE 9180ROCHE DIAGNOSTICS2014-06-04
ISE 9180ROCHE DIAGNOSTICS2013-09-12
COBAS INTEGRA 800ROCHE DIAGNOSTICS2011-12-20
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEMBECKMAN COULTER, INC.2011-10-07
UNICEL DXC 600 SYNCHRON CLINICAL SYSTEMBECKMAN COULTER, INC.2011-09-30
COBAS 6000 C501 MODULEROCHE DIAGNOSTICS2011-09-13
DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD2011-04-06
COBAS 8000 MODULAR ANALYZER SERIESROCHE DIAGNOSTICS2011-03-17
STAT PROFILE CRITICAL CARE XPRESSNOVA BIOMEDICAL2011-03-04
ABL 90 FLEXRADIOMETER MEDICAL APS2011-01-07
ISE 9180ROCHE DIAGNOSTICS2010-03-12
ANALYTICAL P MODULEROCHE DIAGNOSTICS2010-02-23
COBAS C111ROCHE DIAGNOSTICS2009-12-09
COBAS 6000 C501MODULEROCHE DIAGNOSTICS2009-09-23
ANALYTICAL P MODULEROCHE DIAGNOSTICS2009-09-18
ANALYTICAL D MODULEROCHE DIAGNOSTICS2009-09-18
COBAS INTEGRA 400 PLUSROCHE DIAGNOSTICS2009-06-18
ISE 9180ROCHE DIAGNOSTICS2008-11-25
I-STAT CG8+ CARTRIDGEABBOTT POINT OF CARE INC.2008-04-10
ISE 9180ROCHE DIAGNOSTICS CORP.2008-04-03
ISE 9180ROCHE DIAGNOSTICS2008-04-03
ISE 9180ROCHE DIAGNOSTICS2008-03-21
XSYSTEMS CA 15-3 CONTROLSABBOTT LABORATORIES2006-12-04
C8000 CALCIUMABBOTT MANUFACTURING, INC2004-10-11
CALCIUMRAICHEM2001-05-29
CALCIUM REAGENTABBOTT LABORATORIES1994-03-23
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