JJE

Product Code: JJE


Products Classified as JJE

452Analyzer, Chemistry (photometric, Discrete), For Clinical UseDiscrete Photometric Chemistry Analyzer For Clinical Use.

Total Product Life Cycle (TPLC) Devices

452Analyzer, Chemistry (photometric, Discrete), For Clinical UseDiscrete Photometric Chemistry Analyzer For Clinical Use.

FDA Consensus Standards

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use [31042]21 CFR §862.2160 🔎

Pre-market Notifications for JJE

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd
K133519CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CARCAROLINA LIQUID CHEMISTRIES CORP.
K131554RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENTRANDOX LABORATORIES, LTD.
K130915XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACKJAS Diagnostics, Inc.
K130276DIMENSION EXL WITH LM SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS, INC.
K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS
K110035INDIKOTHERMO FISHER SCIENTIFIC OY
K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTECO DIAGNOSTICS
K063144VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEMOrtho-Clinical Diagnostics, Inc.
K051087DIMENSION VISTA INTEGRATED SYSTEMDADE BEHRING, INC.
K042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERSTANBIO LABORATORY
K040958PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240TOKYO BOEKI MEDICAL SYSTEM LTD.
K023764UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100BECKMAN COULTER, INC.
K010500AUTOMATED WORKCELL CONTROL SOFTWARELAB-INTERLINK, INC.

Global Unique Device Identification Database

00380740169978ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
00380740169848ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
00380740169831ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
00380740166441ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
00380740162832ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
00380740161941ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
00380740161323ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
00380740161316ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
00380740160807ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
00380740160791ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
00380740159429ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
00380740159412ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
00380740158460ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
00380740157067ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
00380740157050ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Maude Adverse Events

AU680 CHEMISTRY ANALYZERBECKMAN COULTER2020-03-31
DIMENSION EXL WITH LOCI MODULESIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-31
ARCHITECT C4000 ANALYZERABBOTT LABORATORIES (IRVING IA/CC)2020-03-31
COBAS 6000 C (501) MODULEROCHE DIAGNOSTICS2020-03-31
AU680 CLINICAL CHEMISTRY ANALYZERBECKMAN COULTER2020-03-30
ARCHITECT I1000SR ANALYZERABBOTT LABORATORIES (IRVING IA/CC)2020-03-30
ARCHITECT C4000 ANALYZERABBOTT LABORATORIES (IRVING IA/CC)2020-03-30
ARCHITECT C SYSTEMS MIXERABBOTT LABORATORIES (IRVING ATM)2020-03-30
DIMENSION EXL 200SIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-30
DIMENSION VISTA 500SIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-30
AU480 CHEMISTRY ANALYZERBECKMAN COULTER2020-03-30
ARCHITECT C16000 SYSTEMABBOTT LABORATORIES (IRVING ATM)2020-03-30
ALINITY CI-SERIES LEVEL SENSOR, BULK SOLUTIONABBOTT GMBH2020-03-30
ATELLICA CH REACTION RING SEGMENTSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-27
ATELLICA CH REACTION RING SEGMENTSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-27
ATELLICA CH REACTION RING SEGMENTSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-27
ARCHITECT C16000 SYSTEMABBOTT LABORATORIES (IRVING IA/CC)2020-03-27
ARCHITECT I2000SR ANALYZERABBOTT LABORATORIES (IRVING IA/CC)2020-03-27
AU480 CLINICAL CHEMISTRY ANALYZERBECKMAN COULTER2020-03-27
VIDAS? 3 ANALYZERBIOMERIEUX ITALIA S.P.A.2020-03-27
VIDAS? 3 ANALYZERBIOMERIEUX ITALIA S.P.A.2020-03-27
VIDAS? 3 ANALYZERBIOMERIEUX ITALIA S.P.A.2020-03-27
ARCHITECT I2000SR ANALYZERABBOTT LABORATORIES (IRVING IA/CC)2020-03-27
AU480 CHEMISTRY ANALYZERBECKMAN COULTER2020-03-27
COBAS 8000 COBAS ISE MODULEROCHE DIAGNOSTICS2020-03-27
ADVIA CENTAUR XPTSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-27
COBAS 6000 C (501) MODULEROCHE DIAGNOSTICS2020-03-27
COBAS 6000 C (501) MODULEROCHE DIAGNOSTICS2020-03-27
AU480 CHEMISTRY ANALYZERBECKMAN COULTER2020-03-26
DIMENSION? EXL 200SIEMENS HEALTHCARE DIAGNOSTICS INC2020-03-26
DIMENSION VISTA 1500SIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-26
ALINITY C PROCESSING MODULEABBOTT GMBH2020-03-26
DIMENSION EXL WITH LOCI MODULE (LM) INSTRUMENTSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-26
DIMENSION? EXLSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-26
ATELLICA IM 1300 ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-26
ARCHITECT I2000SR ANALYZERABBOTT LABORATORIES (IRVING IA/CC)2020-03-26
COBAS 6000 C (501) MODULEROCHE DIAGNOSTICS2020-03-26
COBAS C111ROCHE DIAGNOSTICS2020-03-26
ATELLICA SOLUTIONSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-26
ADVIA CENTAUR XPSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-26
AU5800 CHEMISTRY ANALYZERBECKMAN COULTER2020-03-25
DIMENSION VISTA 500SIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-25
AU5800 CLINICAL CHEMISTRY ANALYZERBECKMAN COULTER2020-03-25
COBAS 8000 COBAS ISE MODULEROCHE DIAGNOSTICS2020-03-25
AU680 CLINICAL CHEMISTRY ANALYZERBECKMAN COULTER2020-03-24
AU680 CLINICAL CHEMISTRY ANALYZERBECKMAN COULTER2020-03-24
ARCHITECT I2000SR ANALYZERABBOTT LABORATORIES (IRVING IA/CC)2020-03-24
ATELLICA IM 1300 ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-24
COBAS 6000 C (501) MODULEROCHE DIAGNOSTICS2020-03-24
COBAS 6000 C (501) MODULEROCHE DIAGNOSTICS2020-03-24
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