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JJY

673 FDA 510(k) clearances · Product code

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RecordFirmDate
ACCURUN 117 HBEAG POSITIVE CONTROL (K972048)Boston Biomedica, Inc.1997-08-12
ACCURUN 121 HAV IGM POSITIVE CONTROL (K971657)Boston Biomedica, Inc.1997-08-12
PRECICONTROL TUMOR MARKER 1 AND 2 (K972235)Boehringer Mannheim Corp.1997-08-12
ACCURUN 120 HAV IGG POSITIVE CONTROL (K971406)Boston Biomedica, Inc.1997-08-07
ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL (K972307)Boston Biomedica, Inc.1997-08-07
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL (K972608)Randox Laboratories, Ltd.1997-08-04
NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS (K972070)Nichols Institute Diagnostics1997-06-26
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) (K972214)Roche Diagnostic Systems, Inc.1997-06-24
QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 (K972080)Consolidated Technologies, Inc.1997-06-18
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) (K971952)Bio-Rad1997-06-16
SPECIALITY URINE 1,2 (K971405)Chiron Diagnostics Corp.1997-06-16
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398) (K971954)Bio-Rad1997-06-11
LIQUID LIGAND 1,2,3 (K971071)Chiron Diagnostics Corp.1997-04-23
CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 (K970956)Chiron Diagnostics Corp.1997-04-08
SPINALSCOPICS (K970862)Quantimetrix Corp.1997-04-08
CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 (K970976)Medical Analysis Systems, Inc.1997-04-02
LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 (K970979)Chiron Diagnostics Corp.1997-04-02
TUMOR MARKER CONTROL (K965114)Diagnostic Products Corp.1997-02-20
ELECSYS CALCHECK PROLACTIN (K970147)Boehringer Mannheim Corp.1997-02-10
VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015) (K965048)Johnson & Johnson Clinical Diagnostics, Inc.1997-01-27
LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426) (K965171)Bio-Rad1997-01-13
CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92 (K964640)Canyon Diagnostics, Inc.1996-12-13
BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS (K963770)Biocircuits Corp.1996-12-05
N/T PROTEIN CONTROL SL (K964065)Behring Diagnostics, Inc.1996-11-06
LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363 (K961941)Bio-Rad1996-09-16
LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2 (K961359)Bioprocessing, Inc.1996-09-13
STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3 (K963346)Consolidated Technologies, Inc.1996-09-09
NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT (K962982)Nova Biomedical Corp.1996-08-23
QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET (K961912)Consolidated Technologies, Inc.1996-08-15
NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 (K962997)Nova Biomedical Corp.1996-08-15
ELECSYS PRECICONTROL CARDIAC (K962575)Boehringer Mannheim Corp.1996-07-22
DOCUMENT CARDIAC ASSAYED CONTROL (K961750)Casco Standards1996-07-22
DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL (K962630)Casco Standards1996-07-22
CHEM-CHEX STAT (K961195)Streck Laboratories, Inc.1996-05-15
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2 (K961293)Consolidated Technologies, Inc.1996-05-02
SERUM VOLATILES CONTROL LEVEL 1 & 2 (K955691)Clinical Controls, Inc.1996-04-24
AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 (K955690)Clinical Controls, Inc.1996-04-24
IMMUNOLOGY CONTROL (K960824)Medical Analysis Systems, Inc.1996-04-23
LIPID CONTROL (K960862)Medical Analysis Systems, Inc.1996-04-03
SYSCON TURMOR MARKER CONTROL (K955812)Scantibodies Laboratory, Inc.1996-03-12
N/T PROTEIN CONTROL SY/L, M AND H (K955858)Behring Diagnostics, Inc.1996-02-21
SYSCON CONTROL ASSAYED & UNASSAYED (K954247)Scantibodies Laboratory, Inc.1996-02-14
NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION (K955260)Nova Biomedical Corp.1996-02-02
NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2 (K955264)Nova Biomedical Corp.1996-02-02
NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4 (K955252)Nova Biomedical Corp.1996-02-02
ROCHE CONTROL SERUM N (K954655)Roche Diagnostic Systems, Inc.1995-12-21
ROCHE CONTROL SERUM P (K954656)Roche Diagnostic Systems, Inc.1995-12-21
LIQUICHEK ETHANOL/AMMONIA CONTROL (K955024)Bio-Rad1995-11-28
MAS LIQUID URINALYSIS CONTROL (K954323)Medical Analysis Systems, Inc.1995-11-09
VIROTROL IV (K954298)Blackhawk Biosystems, Inc.1995-11-01
AALTO SCIENTIFIC LIQUID CARDIAC CONTROL (K954074)Aalto Scientific, Ltd.1995-10-07
HEMA-TROL Q-CHECK (K952385)Medical Specialties Intl., Inc.1995-09-25
CSF LIQUID CEREBROSPINAL FLUID CONTROL (K952877)Medical Analysis Systems, Inc.1995-08-24
COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI (K942647)Scantibodies Laboratory, Inc.1995-07-12
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM (K950802)International Enzymes, Inc.1995-06-01
PROSTAT CONTROL (K943394)Quantimetrix Corp.1995-05-23
LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3 (K945651)Bio-Rad1995-05-16
BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 (K951749)Biocell Laboratories, Inc.1995-05-15
VIGIL MULTICHEK CONTROLS (K951170)Beckman Instruments, Inc.1995-04-20
DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET (K950469)Casco Standards1995-04-11
BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN ELECTROPHORESIS CONTROL (K944728)Bioresource Technology, Inc.1995-03-23
LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3 (K944525)Medical Analysis Systems, Inc.1995-03-21
KENLOR HUMAN SPINAL FLUID CONTROL (K950326)Kenlor Industries, Inc.1995-03-20
PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED (K942458)Randox Laboratories, Ltd.1995-03-13
RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL (K950399)Bionostics, Inc.1995-02-22
LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2 (K946049)Clinical Controls, Inc.1995-02-10
QUANITITATE GBCC VERIFIER SET (K944454)Beckman Instruments, Inc.1995-01-17
QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE) (K944455)Beckman Instruments, Inc.1995-01-17
DYE CHECK STRIPS 545-630 (K943729)Awareness Technology, Inc.1994-12-29
DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL (K945315)Casco Standards1994-12-09
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E (K944486)International Enzymes, Inc.1994-12-02
QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE) (K944452)Beckman Instruments, Inc.1994-12-02
LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E (K944513)International Enzymes, Inc.1994-12-02
PROCHEQ 1 & 2 (K944059)Prisma Systems1994-11-15
HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 (K935599)Clinical Controls, Inc.1994-10-31
VIROTROL TORCH (K942295)Blackhawk Biosystems, Inc.1994-10-07
MULTI ANALYTE LINEARITY SET (K936245)Teco Diagnostics1994-10-04
BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT (K943754)Bionostics, Inc.1994-09-14
BILIRUBIN PLUS/PEDIATRIC CONTROLS (K943290)Medi-Tech, Inc.1994-09-14
TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2 (K941328)Medical Analysis Systems, Inc.1994-08-18
WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 (K941876)More Diagnostics1994-07-28
SERUM VOLATILES CONTROL - LEVELS 1 AND 2 (K941698)More Diagnostics1994-07-28
ACS CARDIO-TROL CONTROL (K941115)Analytical Control Systems, Inc.1994-07-20
N/T PROTEIN CONTROL SY/L, M, AND H (K941912)Behring Diagnostics, Inc.1994-06-16
VIGIL PRX CHEMISTRY CONTROL (K936184)Beckman-Diagnostic Systems Group1994-04-15
TMC I, II (K930534)Ciba Corning Diagnostics Corp.1994-04-04
FERTILITY PLUS 1, 2, 3 (K935219)Ciba Corning Diagnostics Corp.1994-03-22
ACS O DILVENT PROTEIN DILUTION MATRIX (K940397)Analytical Control Systems, Inc.1994-03-11
PARA 4 PLUS (K933844)Streck Laboratories, Inc.1993-12-27
DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3 (K933437)Baxter Diagnostics, Inc.1993-10-28
LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2 (K934357)Bio-Rad1993-10-21
TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3 (K934056)Medical Analysis Systems, Inc.1993-10-18
DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2 (K933435)Baxter Diagnostics, Inc.1993-09-24
BECKMAN VIGIL PLUS CONTROL (K930850)Beckman Instruments, Inc.1993-09-01
LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 (K933317)Bio-Rad1993-08-11
DADE(R) TUMOR MARKER CONTROL (K924919)Baxter Diagnostics, Inc.1993-08-05
TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3 (K931366)Medical Analysis Systems, Inc.1993-07-28
DOCUMENT ENZYME (K932458)Casco Standards1993-06-29
LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II (K932076)Bio-Rad1993-06-29
MULTITROL IMMUNOLOGY CONTROL (K923663)Behring Diagnostics, Inc.1993-06-28
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