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JIX

302 FDA 510(k) clearances · Product code

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RecordFirmDate
DIMENSION DRUG CALIBRATOR, MODEL DC22B (K011035)Dade Behring, Inc.2001-06-14
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (K010652)Sigma Diagnostics, Inc.2001-03-30
LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR (K010030)Synergent Biochem Inc.-Clinical Controls Div.2001-02-14
N PROTEIN STANDARD SL (K002804)Dade Behring, Inc.2000-10-05
CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 (K001484)Alko Diagnostic Corp.2000-06-19
ELECSYS CORTISOL CALCHECK (K000576)Roche Diagnostics Corp.2000-03-21
K-ASSAY MULTI-ANALYTE CALIBRATOR (K993853)Kamiya Biomedical Co.1999-12-27
K-ASSAY APO A1/B CALIBRATOR SET (K993606)Kamiya Biomedical Co.1999-11-26
HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT (K992845)Elan Holdings, Inc.1999-10-18
HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 (K993098)Data Medical Associates, Inc.1999-10-08
OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2 (K992086)Olympus America, Inc.1999-08-19
K-ASSAY MICROALBUMIN CALIBRATOR SET (K991166)Kamiya Biomedical Co.1999-06-10
MODIFICATION OF N PROTEIN STANDARD SL (K991181)Dade Behring, Inc.1999-06-01
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) (K990460)Roche Diagnostics Corp.1999-03-22
MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR (K984425)Boehringer Mannheim Corp.1999-01-20
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 (K984014)Beckman Coulter, Inc.1998-12-23
PRECISET SERUM PROTEINS CALIBRATOR (K983469)Boehringer Mannheim Corp.1998-11-25
RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR (K982767)Raichem1998-09-21
ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 (K982501)Alko Diagnostic Corp.1998-09-01
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 (K981706)Abbott Laboratories1998-07-09
CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO (K981795)Thermo Bioanalysis Corp.1998-06-12
OLYMPUS SERUM PROTEIN MULTICALIBRATOR (K981305)Olympus America, Inc.1998-05-07
DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 (K981436)Casco Standards1998-04-24
BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS (K974825)Boehringer Mannheim Corp.1998-01-30
MICROPROTEIN STANDARD KIT (K974290)Verichem Laboratories, Inc.1997-12-19
BECKMAN CALIBRATOR 2 (CAL2) (K973932)Beckman Instruments, Inc.1997-12-15
BECKMAN URINE PROTEIN CALIBRATOR (UCAL) (K973928)Beckman Instruments, Inc.1997-12-01
MATRIX PLUS MULTI-CALIBRATOR KIT (K973345)Verichem Laboratories, Inc.1997-10-29
AMMONIA/IRON STANDARD KIT (K972333)Verichem Laboratories, Inc.1997-07-23
SYNCHRON SYSTEMS CAL 5 PLUS (K971283)Beckman Instruments, Inc.1997-06-03
SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD (K971333)Beckman Instruments, Inc.1997-05-23
STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) (K970921)Alko Diagnostic Corp.1997-04-08
N RHEUMATOLOGY STANDARD SL (K964527)Behring Diagnostics, Inc.1997-01-15
ELECSYS CALCHECK FSH (K964829)Boehringer Mannheim Corp.1996-12-16
N PROTEIN STRANDARD SL (K964062)Behring Diagnostics, Inc.1996-11-21
SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2 (K963543)Sigma Diagnostics, Inc.1996-10-30
CEDIA CARDIAC TDM MULTI-CALS (K962269)Boehringer Mannheim Corp.1996-10-29
SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1 (K963533)Sigma Diagnostics, Inc.1996-10-29
DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR (K962629)Casco Standards1996-09-13
N CRP STANDARD SY (K962406)Behring Diagnostics, Inc.1996-07-16
N PROTEIN STANDARD PY (K962410)Behring Diagnostics, Inc.1996-07-16
CALIBRATION SERUM LEVEL 1 & 2 (K955489)Randox Laboratories, Ltd.1996-06-21
CEDIA CORE TDM MULTI-CAL (K961659)Boehringer Mannheim Corp.1996-06-13
DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS (K960103)Dade Intl., Inc.1996-04-26
ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS (K960085)Alko Diagnostic Corp.1996-03-11
CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT (K955154)Alko Diagnostic Corp.1995-12-11
APOLIPOPROTEIN CALIBRATOR (APO-CAL) (K953979)Beckman Instruments, Inc.1995-10-03
ROCHE CALIBRATOR SERUM (K942706)Roche Diagnostic Systems, Inc.1995-09-20
ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR (K952282)Roche Diagnostic Systems, Inc.1995-09-15
HICHEM ISE STANDARDS KIT 70011 (K953863)Hichem Diagnostics1995-09-06
ALKO CAL PACKS FOR CORNING 654 ANALYZERS (K944922)Alko Diagnostic Corp.1995-02-10
ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS (K945966)Alko Diagnostic Corp.1995-02-10
CALIBRATOR (K943012)Prisma Systems1994-11-28
DOCUMENTR AMMONIA/ETHANOLCALIBRATOR (K944639)Casco Standards1994-11-15
FLUIDS PACK FOR CORING 238 (K940760)Alko Diagnostic Corp.1994-09-06
DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR (K941219)Dupont Medical Products1994-08-09
ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS (K942549)Alko Diagnostic Corp.1994-07-28
SYNERMEDIR CAL I AND SYNERMED IR CAL II (K940571)Synermed, Inc.1994-04-21
ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM (K934607)Alko Diagnostic Corp.1994-03-28
ACA PLUS FERRITIN CALIBRATOR (K935543)E.I. Dupont DE Nemours & Co., Inc.1994-03-22
REAGENTS FOR HITACHI ISE (K933383)Alko Diagnostic Corp.1994-03-09
REAGENTS FOR ORION 1020, AND RELATED ANALYZERS (K935018)Alko Diagnostic Corp.1994-01-18
CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER (K935547)Alko Diagnostic Corp.1994-01-18
CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR (K925464)Alko Diagnostic Corp.1994-01-13
ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS (K930231)Alko Diagnostic Corp.1994-01-13
ALKO FLUIDS PACKS FOR NOVA ANALYZERS (K930199)Alko Diagnostic Corp.1994-01-13
REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA) (K925385)Alko Diagnostic Corp.1994-01-13
QUANTIMETRIX BLOOD GLUCOSE CONTROLS (K932623)Quantimetrix Corp.1993-12-09
REAGENTS FOR COBAS ISE MODULE (K934701)Alko Diagnostic Corp.1993-12-02
N-ASSAY TIA MICROALBUMIN CALIBRATOR SET (K934143)Crestat Diagnostics, Inc.1993-11-05
CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323 (K932768)Helena Laboratories1993-10-18
DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM (K933955)E.I. Dupont DE Nemours & Co., Inc.1993-10-13
SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (K933693)Sigma Chemical Co.1993-10-13
SIGMA CX-3 CALIBRATION STANDARD LEVEL 1 (K933702)Sigma Chemical Co.1993-10-08
ACE CLINICAL CHEMISTRY SYSTEM (K930104)Schiapparelli Biosystems, Inc.1993-08-23
SYSTEMATE PLUS CALIBRATOR (K925101)Em Diagnostic Systems, Inc.1993-02-23
ISE CALIBRATOR FOR DUPONT DIMENSION (K926518)Alko Diagnostic Corp.1993-01-28
ROCHE CALIBRATOR SERUM (K922043)Roche Diagnostic Systems, Inc.1992-06-16
CIBA CORNING ACS FOLATE IMMUNOASSAY (K921678)Ciba Corning Diagnostics Corp.1992-06-09
CALIBRATOR (K915797)Alko Diagnostic Corp.1992-01-30
IL TEST(TM) CALIBRATION SET SP (K914909)Instrumentation Laboratory CO1992-01-22
DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR (K914917)E.I. Dupont DE Nemours & Co., Inc.1991-12-13
ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR (K914750)Roche Diagnostic Systems, Inc.1991-11-22
PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION (K910309)Baxter Healthcare Corp1991-03-29
ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR (K904767)Analytical Control Systems, Inc.1990-12-26
HI CHEM PROTEIN/LIPIDS LINEARITY (K903888)Hichem Diagnostics1990-09-27
PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II (K903913)Baxter Healthcare Corp1990-09-27
MULTI ANALYTE MIXTURE, CALIBRATORS (K902675)Phoenix Diagnostics, Inc.1990-07-31
COBAS READY CALIBRATOR KIT (K897097)Roche Diagnostic Systems, Inc.1990-06-26
CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE (K897177)Nova Biomedical Corp.1990-03-27
ROCHE STANDARDS FOR THE COBAS ISE MODULE (K897071)Roche Diagnostic Systems, Inc.1990-03-09
SODIUM AND POTASSIUM STANDARD (K895717)Data Medical Associates, Inc.1990-01-11
HI CHEM CALIBRATOR A+ (K895135)Hichem Diagnostics1989-10-23
HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2 (K890583)Hichem Diagnostics1989-03-13
UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS (K884693)Biomedical Research & Development Laboratories, Inc.1988-12-15
CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM (K884227)A-Kem, Inc.1988-12-09
MULTI-CHEMISTRY LINEARITY STANDARD (K875285)Verichem Laboratories, Inc.1988-09-02
DC-LIQUICAL CATALOGUE #SE-030 (K882258)Diagnostic Chemicals, Ltd. (Usa)1988-08-30
TOTAL PROTEIN/ALBUMIN STANDARD (K882116)Verichem Laboratories, Inc.1988-06-24
PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II (K881258)Baxter Healthcare Corp1988-05-27
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