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JIT

245 FDA 510(k) clearances · Product code

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RecordFirmDate
RDI EXTENDED RANGE CRP CALIBRATOR SET (K030772)Reference Diagnostics, Inc.2003-04-11
FASTPACK TESTOSTERONE CALIBRATOR (K022533)Qualigen, Inc.2002-09-30
CALIBRATING MATERIAL, BUFFERS, STANDARD (K022027)Mission Diagnostics2002-07-22
ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR (K021535)Bayer Diagnostics Corp.2002-06-27
ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR (K021532)Bayer Diagnostics Corp.2002-06-27
RDI HS CRP CALIBRATOR SET (K021607)Reference Diagnostics, Inc.2002-06-27
DIMENSION TPSA CALIBRATOR, MODEL #RC459 (K020980)Dade Behring, Inc.2002-06-21
DIMENSION ALDL CALIBRATOR, MODEL DC131 (K020723)Dade Behring, Inc.2002-05-08
CALIBRATING MATERIAL, CAL-PAK, BUFFERS (K020894)Mission Diagnostics2002-04-29
CHEMISTRY CALIBRATOR (K020454)Jas Diagnostics, Inc.2002-04-08
CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS (K020596)Diamond Diagnostics, Inc.2002-03-23
STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE (K013850)Diamond Diagnostics, Inc.2001-12-21
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS (K012900)Beckman Coulter, Inc.2001-10-16
VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D (K012367)Nichols Institute Diagnostics2001-10-09
STRATUS CS TROPONIN I CALIBRATOR (K012233)Dade Behring, Inc.2001-09-11
MODIFICATION TO ELECSYS FSH II CALSET (K012399)Roche Diagnostics Corp.2001-08-24
WAKO IMMUNOASSAY CALIBRATOR SET (K010332)Wako Chemicals USA, Inc.2001-08-01
WAKO LIPID CALIBRATOR (K010334)Wako Chemicals USA, Inc.2001-06-25
RAICHEM CREATININE URINE STANDARD (K011126)Hemagen Diagnostics, Inc.2001-05-02
DIMENSION CTNI CALIBRATOR (K010314)Dade Behring, Inc.2001-04-20
N PROTEIN STANDARD UY CALIBRATOR (K003501)Dade Behring, Inc.2001-03-15
ELECSYS TESTOSTERONE CALSET II (K003411)Roche Diagnostics Corp.2001-03-01
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 (K010208)Dade Behring, Inc.2001-02-20
ELECSYS FSH CALSET II (K003409)Roche Diagnostics Corp.2001-01-26
FASTPACK CALIBRATORS (K003096)Qualigen, Inc.2000-11-30
ACCESS ULTRASENSITIVE HGH CALIBRATORS (K003098)Beckman Coulter, Inc.2000-11-20
DIRECT TIBC CALIBRATOR (K000783)Reference Diagnostics, Inc.2000-05-04
DIMENSION SPECIAL PROTEIN CALIBRATOR (K994291)Dade Behring, Inc.2000-03-01
GENZYME DIRECT AMYLASE VERIFIER (K993132)Genzyme Corp.1999-10-04
ELECSYS ESTRADIOL CALSET II (K992981)Roche Diagnostics Corp.1999-09-24
N PROTEIN STANDARD UY (K991705)Dade Behring, Inc.1999-07-15
OPUS TROPONIN I CALIBRATOR (K991176)Dade Behring, Inc.1999-07-01
REVISED C-REACTIVE PROTEIN CALIBRATOR (K990824)Dade Behring, Inc.1999-04-16
DIMENSION SPECIAL PROTEIN CALIBRATOR (K990554)Dade Behring, Inc.1999-03-22
DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR (K984193)Dade Behring, Inc.1998-12-14
DIMENSION AHDL CALIBRATOR (K983850)Dade Behring, Inc.1998-11-18
STRATUS CS TROPONIN I CALIBRATOR (K983722)Dade Behring, Inc.1998-11-04
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR (K983693)Dade Behring, Inc.1998-11-04
FERRITIN CALIBRATOR (K983548)Dade Behring, Inc.1998-10-27
OLYMPUS SERUM PROTEIN MULTICALIBRATOR, (K981854)Olympus Diagnostica GmbH1998-08-18
PREALBUMIN CALIBRATOR (K982292)Dade Behring, Inc.1998-08-13
STRATUS CS CKMB CALPAK (K981097)Dade Behring, Inc.1998-04-16
STRATUS CS TROP CALPAK (K981100)Dade Behring, Inc.1998-04-16
STRATUS CS MYO CALPAK (K981101)Dade Behring, Inc.1998-04-15
CARDIAC TROPONIN-I (TROP) CALIBRATOR (K973668)Dade Intl., Inc.1997-10-20
PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR (K973100)Dade Chemistry Systems, Inc.1997-09-29
ELECSYS CEA ASSAY (K964368)Boehringer Mannheim Corp.1997-06-16
MMB CALIBRATOR (K970336)Dade Chemistry Systems, Inc.1997-03-03
THYROID CALIBRATOR (K970389)Dade Chemistry Systems, Inc.1997-02-18
FERRITIN CALIBRATOR (K963493)Dade Chemistry Systems, Inc.1996-12-03
ACA PLUS FT4 CALIBRATOR (K962594)Dade Intl., Inc.1996-08-15
STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY (K954326)Solarcare Technologies Corp,Inc.1996-07-23
DUPONT LIPASE CALIBRATOR (K952815)Dupont Medical Products1995-08-31
FLUIDS PACK (K944516)Alko Diagnostic Corp.1994-11-02
LIPASE CALIBRATOR (K943704)The DU Pont Co.1994-09-14
URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR (K934843)E.I. Dupont DE Nemours & Co., Inc.1994-03-11
TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL (K913371)Creative Laboratory Products, Inc.1991-11-08
CHOLESTEROL CALIBRATOR SET (K910962)Casco Standards1991-03-29
ELECTROPHORESIS CONTROL (K910160)Seradyn, Inc.1991-02-27
SECONDARY CALIBRATORS (K904698)Bionostics, Inc.1990-11-28
COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN. (K895648)Ventrex Laboratories, Inc.1990-01-18
COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. (K895649)Ventrex Laboratories, Inc.1990-01-18
OSMOMETER STANDARD SOLUTIONS (K892329)D.R.G. Scientific Industries1989-10-31
CHLORIDE STANDARDS ITEM #SR1041 (K891999)Em Diagnostic Systems, Inc.1989-08-15
DOCUMENT(TM) URIC ACID LINEARITY TEST SET (K893139)Casco Standards1989-07-20
DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET (K884197)Casco Standards1988-12-14
BILIRUBIN STANDARD (K882059)Verichem Laboratories, Inc.1988-10-25
BINAS LUTEINIZING HORMONE IRMA TEST KIT (K883306)Binax, Inc.1988-10-06
DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 (K882259)Diagnostic Chemicals, Ltd. (Usa)1988-07-21
PARAMAX ISE CHLORIDE CALIBRATOR (K873743)Baxter Healthcare Corp1987-12-14
G-GT STANDARD CALIBRATOR (K871759)Wako Chemicals USA, Inc.1987-09-29
BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052 (K872073)American Monitor Corp.1987-09-11
BILE ACIDS CALIBRATOR (K872451)Sigma Diagnostics, Inc.1987-08-21
TOTAL BILIRUBIN STANDARD CALIBRATOR (K872263)Wako Chemicals USA, Inc.1987-07-22
CREATININE STANDARD SOLUTION CALIBRATOR (K871756)Wako Chemicals USA, Inc.1987-05-27
NEFA STANDARD SOLUTION CALIBRATOR (K871763)Wako Chemicals USA, Inc.1987-05-26
UREA N STANDARD SOLUTION CALIBRATOR (K871767)Wako Chemicals USA, Inc.1987-05-26
MAGNESIUM STANDARD SOLUTION CALIBRATOR (K871762)Wako Chemicals USA, Inc.1987-05-26
ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8 (K871150)Beckman Instruments, Inc.1987-05-26
URIC ACID STANDARD SOLUTION CALIBRATOR (K871768)Wako Chemicals USA, Inc.1987-05-26
GLUCOSE STANDARD SOLUTION CALIBRATOR (K871758)Wako Chemicals USA, Inc.1987-05-26
TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR (K871766)Wako Chemicals USA, Inc.1987-05-26
INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR (K871764)Wako Chemicals USA, Inc.1987-05-26
PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR (K871765)Wako Chemicals USA, Inc.1987-05-26
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR (K870673)E.I. Dupont DE Nemours & Co., Inc.1987-03-19
EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95 (K862525)Em Diagnostic Systems, Inc.1986-08-19
CHOLESTEROL CALIBRATORS (K861314)Sigma Diagnostics, Inc.1986-07-01
ABSORBANCE (ABS) TEST PAK (K854784)Diagnostic Systems1985-12-19
LIQUI-SERA CHEM. MULTIPLE CALIBRATORS (K853887)Biodiagnostic Intl1985-09-30
ABSORBANCE TEST SOLUTION (K853533)Diagnostic Systems1985-09-16
CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET (K852461)Medical Analysis Systems, Inc.1985-07-12
DIRECT BILIRUBEN CALIBRATIONS (K852067)Data Medical Associates, Inc.1985-05-31
CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/ (K851670)Medical Analysis Systems, Inc.1985-05-10
TRIGLYCERIDE CALIBRATOR (K844468)Sigma Diagnostics, Inc.1984-12-11
FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS (K844047)Fisher Diagnostics1984-11-09
ROCHE STANDARDS FOR URIC ACID (K843112)Roche Diagnostic Systems, Inc.1984-09-13
ACTH STANDARD MATRIX (K842099)Diagnostic Systems Laboratories, Inc.1984-08-17
ALCOHOL & AMMONIA CALIBRATOR II (K840772)American Dade1984-04-13
ALCOHOL & AMMONIA CALIBRATOR I (K840771)American Dade1984-04-13
CARBON DIOXIDE CALIBRATOR I (K840774)American Dade1984-04-04
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