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Panels › Clinical Chemistry › Product code JIX · Class 2

Calibrator, Multi-Analyte Mixture

Regulation 862.1150

0510(k)s in 12 months (302 all time)
1recalls in 12 months (73 all time)
60recalls that name a 510(k)
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Top companies in JIX

Decided510(k)Device and applicantCode
Feb 10, 1995K945966ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS
Alko Diagnostic Corp.
JIX
Feb 10, 1995K944922ALKO CAL PACKS FOR CORNING 654 ANALYZERS
Alko Diagnostic Corp.
JIX
Nov 28, 1994K943012CALIBRATOR
Prisma Systems
JIX
Nov 15, 1994K944639DOCUMENTR AMMONIA/ETHANOLCALIBRATOR
Casco Standards
JIX
Sep 6, 1994K940760FLUIDS PACK FOR CORING 238
Alko Diagnostic Corp.
JIX
Aug 9, 1994K941219DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR
Dupont Medical Products
JIX
Jul 28, 1994K942549ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS
Alko Diagnostic Corp.
JIX
Apr 21, 1994K940571SYNERMEDIR CAL I AND SYNERMED IR CAL II
Synermed, Inc., CA
JIX
Mar 28, 1994K934607ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM
Alko Diagnostic Corp.
JIX
Mar 22, 1994K935543ACA PLUS FERRITIN CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
JIX
Mar 9, 1994K933383REAGENTS FOR HITACHI ISE
Alko Diagnostic Corp.
JIX
Jan 18, 1994K935547CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER
Alko Diagnostic Corp.
JIX
Jan 18, 1994K935018REAGENTS FOR ORION 1020, AND RELATED ANALYZERS
Alko Diagnostic Corp.
JIX
Jan 13, 1994K930231ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS
Alko Diagnostic Corp.
JIX
Jan 13, 1994K930199ALKO FLUIDS PACKS FOR NOVA ANALYZERS
Alko Diagnostic Corp.
JIX
Jan 13, 1994K925464CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR
Alko Diagnostic Corp.
JIX
Jan 13, 1994K925385REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)
Alko Diagnostic Corp.
JIX
Dec 9, 1993K932623QUANTIMETRIX BLOOD GLUCOSE CONTROLS
Quantimetrix Corp.
JIX
Dec 2, 1993K934701REAGENTS FOR COBAS ISE MODULE
Alko Diagnostic Corp.
JIX
Nov 5, 1993K934143N-ASSAY TIA MICROALBUMIN CALIBRATOR SET
Crestat Diagnostics, Inc.
JIX
Oct 18, 1993K932768CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323
Helena Laboratories
JIX
Oct 13, 1993K933955DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM
E.I. Dupont DE Nemours & Co., Inc.
JIX
Oct 13, 1993K933693SIGMA CX-3 CALIBRATION STANDARD LEVEL 2
Sigma Chemical Co.
JIX
Oct 8, 1993K933702SIGMA CX-3 CALIBRATION STANDARD LEVEL 1
Sigma Chemical Co.
JIX
Aug 23, 1993K930104ACE CLINICAL CHEMISTRY SYSTEM
Schiapparelli Biosystems, Inc.
JIX
Feb 23, 1993K925101SYSTEMATE PLUS CALIBRATOR
Em Diagnostic Systems, Inc.
JIX
Jan 28, 1993K926518ISE CALIBRATOR FOR DUPONT DIMENSION
Alko Diagnostic Corp.
JIX
Jun 16, 1992K922043ROCHE CALIBRATOR SERUM
Roche Diagnostic Systems, Inc.
JIX
Jun 9, 1992K921678CIBA CORNING ACS FOLATE IMMUNOASSAY
Ciba Corning Diagnostics Corp.
JIX
Jan 30, 1992K915797CALIBRATOR
Alko Diagnostic Corp.
JIX
Jan 22, 1992K914909IL TEST(TM) CALIBRATION SET SP
Instrumentation Laboratory CO
JIX
Dec 13, 1991K914917DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
JIX
Nov 22, 1991K914750ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR
Roche Diagnostic Systems, Inc.
JIX
Mar 29, 1991K910309PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION
Baxter Healthcare Corp
JIX
Dec 26, 1990K904767ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR
Analytical Control Systems, Inc.
JIX
Sep 27, 1990K903913PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II
Baxter Healthcare Corp
JIX
Sep 27, 1990K903888HI CHEM PROTEIN/LIPIDS LINEARITY
Hichem Diagnostics
JIX
Jul 31, 1990K902675MULTI ANALYTE MIXTURE, CALIBRATORS
Phoenix Diagnostics, Inc.
JIX
Jun 26, 1990K897097COBAS READY CALIBRATOR KIT
Roche Diagnostic Systems, Inc.
JIX
Mar 27, 1990K897177CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE
Nova Biomedical Corp.
JIX
Mar 9, 1990K897071ROCHE STANDARDS FOR THE COBAS ISE MODULE
Roche Diagnostic Systems, Inc.
JIX
Jan 11, 1990K895717SODIUM AND POTASSIUM STANDARD
Data Medical Associates, Inc.
JIX
Oct 23, 1989K895135HI CHEM CALIBRATOR A+
Hichem Diagnostics
JIX
Mar 13, 1989K890583HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2
Hichem Diagnostics
JIX
Dec 15, 1988K884693UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS
Biomedical Research & Development Laboratories, Inc.
JIX
Dec 9, 1988K884227CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM
A-Kem, Inc.
JIX
Sep 2, 1988K875285MULTI-CHEMISTRY LINEARITY STANDARD
Verichem Laboratories, Inc.
JIX
Aug 30, 1988K882258DC-LIQUICAL CATALOGUE #SE-030
Diagnostic Chemicals, Ltd. (Usa), CA
JIX
Jun 24, 1988K882116TOTAL PROTEIN/ALBUMIN STANDARD
Verichem Laboratories, Inc.
JIX
May 27, 1988K881258PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II
Baxter Healthcare Corp
JIX

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