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JJY

673 FDA 510(k) clearances · Product code

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RecordFirmDate
AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA (K882736)Amersham Corp.1988-10-11
AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190 (K882728)Amersham Corp.1988-10-06
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL (K883147)Utak Laboratories, Inc.1988-10-06
AMERLITE FREE THYROID CONTROL SERA LAN.4002 (K883124)Amersham Corp.1988-09-30
LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL (K883247)Quantimetrix Medical Industries1988-09-13
A.QC CHEMISTRY CONTROL LEVEL 2 (K883012)Arden Medical Systems, Inc.1988-09-09
AMERLITE TOTAL THYROID CONTROL SERA LAN.4001 (K882727)Amersham Corp.1988-08-08
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II (K882542)Bio-Rad1988-07-21
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL (K881503)Baxter Healthcare Corp1988-07-08
CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS (K881437)Hichem Diagnostics1988-07-06
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN (K881438)Hichem Diagnostics1988-07-06
CLP LIPOPROTEIN ELECTROPHORESIS CONTROL (K881113)Creative Laboratory Products, Inc.1988-07-01
SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS (K881436)Hichem Diagnostics1988-06-02
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693 (K881229)Em Diagnostic Systems, Inc.1988-05-27
MULTI-FUNCTION BLOOD GAS CONTROL (K880447)Bionostics, Inc.1988-05-27
URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II (K881275)Fisher Scientific Co., LLC1988-05-16
LYPHOCHEK SPINAL FLUID CONTROL (HUMAN) (K880494)Bio-Rad1988-03-03
DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL (K880175)Baxter Healthcare Corp1988-03-01
LYPHOCHEK WHOLE BLOOD CONTROL (K874731)Bio-Rad1988-02-18
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II (K874280)Bio-Rad1988-01-21
REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM (K874809)Biotrol, USA, Inc.1988-01-07
REFERENCE ASSAYED CHEMISTRY CONTROL SERUM (K874810)Biotrol, USA, Inc.1988-01-05
DC-TROL LEVEL 1 OR 2 (K874772)Diagnostic Chemicals, Ltd. (Usa)1988-01-05
LIQUI-SERA SPINAL FLUID CONTROL (K874459)Biodiagnostic Intl1987-12-29
PRECINORM L (K874230)Boehringer Mannheim Corp.1987-11-23
A-QC CLINICAL CHEMISTRY CONTROL (K873611)Arden Medical Systems, Inc.1987-10-20
BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM (K872785)Biotrol, USA, Inc.1987-08-26
BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL (K872777)Biotrol, USA, Inc.1987-08-26
LIPID CONTROL SERUM (K872376)Biological Industries1987-08-05
DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR (K871977)American Dade1987-07-09
UNASSAYED CONTROL SERUM, NORMAL (BOVINE) (K872304)Vanguard Diagnostic Systems1987-07-07
UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE) (K872303)Vanguard Diagnostic Systems1987-07-07
LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II (K872227)Bio-Rad1987-07-06
QM2/QM300 CONTROL A PACK (K871342)Kallestad Diag, A Div. of Erbamont, Inc.1987-05-21
CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II (K871537)Canyon Diagnostics, Inc.1987-05-06
LIQUID CHEMISTRY CONTROL, LEVEL I (K870684)U. S. Diagnostics, Inc.1987-04-06
SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) (K871058)Fisher Scientific Co., LLC1987-04-06
LIQUID CHEMISTRY CONTROL, LEVEL II (K870683)U. S. Diagnostics, Inc.1987-04-06
DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET (K870252)Casco Standards1987-02-20
CHEMTROL(TM) (K862565)G.B.F. Industries, Inc.1987-01-13
TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS (K861202)Nms Pharmaceuticals, Inc.1987-01-09
LIQUI-SERA COMBO LIGAND/TDM CONTROLS (K863849)Biodiagnostic Intl1986-11-24
MULTI-ANALYTE LIN-TROL (K863751)Sigma Diagnostics, Inc.1986-11-24
SERACON CT REFERENCE (K863648)Bhp Diagnostix, Inc.1986-10-29
ABNORMAL SPINAL FLUID CONTROL (K863745)Ciba Corning Diagnostics Corp.1986-10-07
QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL (K861420)Quantimetrix Corp.1986-09-16
THERAPEUTIC DRUG MONITORING CONTROL SET (K862963)American Monitor Corp.1986-09-15
CHEMVARION(TM) (K862586)G.B.F. Industries, Inc.1986-08-04
GAS-TRAK (K862278)United Diagnostics, Inc.1986-08-04
UTAK-STABBS TOXICOLOGY CONTROL (K862420)Utak Laboratories, Inc.1986-08-04
CHEMTROL(TM) (K862587)G.B.F. Industries, Inc.1986-08-04
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL (K862185)Bio-Rad1986-08-04
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED (K860999)Ciba Corning Diagnostics Corp.1986-07-02
SOMAS LIQUID URINE CONTROL (K862179)Somas Medical Industries, Inc.1986-07-01
MULTI-4 CO-OXIMETER CONTROL (K861901)Allied Instrumentation Laboratory1986-06-17
STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III (K860906)American Dade1986-05-29
IRON PROCEDURE (K861603)Data Medical Associates, Inc.1986-05-23
QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID (K860942)Quantimetrix Corp.1986-05-23
CONTROL SERA LEVEL VALUES (MG/DL) (K861567)E.I. Dupont DE Nemours & Co., Inc.1986-05-23
THERACHEM-PLUS, TRI-LEVEL TDC (TM) (K861185)Fisher Scientific Co., LLC1986-05-23
QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID (K861448)Quantimetrix Medical Industries1986-04-28
GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED (K861068)Ciba Corning Diagnostics Corp.1986-04-07
PRECINORM IM AND PRECIPATH IM (K860970)Boehringer Mannheim Corp.1986-04-03
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED (K860998)Ciba Corning Diagnostics Corp.1986-04-03
GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED (K861000)Ciba Corning Diagnostics Corp.1986-04-03
BOVINE CHEMISTRY CONTROL I.X AND II.X (K860355)American Dade1986-03-17
CALIBRATION REFERENCE I & II (K855035)Integrated Medical Systems Int'L., Inc.1986-03-17
CHEMISTRY CONTROL N & A (K855036)Integrated Medical Systems Int'L., Inc.1986-03-17
CANTROL ELECTROPHORESIS CONTROL (K854931)Canyon Diagnostics, Inc.1986-01-17
RANGE-CHEK (K854789)American Monitor Corp.1986-01-13
CRITIC - SF, ASSAYED (K854967)Dimension Diagnostics1986-01-07
CRITIC C LEVEL I & II (K853943)Dimension Diagnostics1985-12-23
ACCURACY (K854119)Columbia Diagnostics, Inc.1985-10-25
LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) (K853906)Biodiagnostic Intl1985-10-04
QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL (K853931)Quantimetrix Corp.1985-10-04
DC LIQUITROL LEVEL 1 & 2 (K852753)Diagnostic Chemicals, Ltd. (Usa)1985-08-02
SPINAL FLUID CONTROL (K851820)Irvine Scientific1985-07-15
QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) (K852418)Amf Biological and Diagnostics Co.1985-07-15
DC-LIP, CATALOGUE NUMBER SE-020 (K852594)Diagnostic Chemicals, Ltd. (Usa)1985-07-12
COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY (K851942)Coulter Electronics, Inc.1985-05-31
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO (K850574)American Dade1985-04-12
DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H (K850575)American Dade1985-04-10
PRECINORM H & PRECIPATH H (K850017)Boehringer Mannheim Corp.1985-03-05
IMA-TROL IMMUNOASSAY CONTROL (K844848)Dimension Diagnostics1985-03-01
ULTROSER G (K844413)Lkb Instruments, Inc.1985-02-27
PARAGON TRICHECK ELECTROPHORESIS CONTROL (K844996)Beckman Instruments, Inc.1985-02-06
GELMAN TRIPHOR CONTROL (K850202)Gelman Sciences, Inc.1985-02-06
LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN (K844125)Bio-Rad1985-01-08
UROL-QUAL (K844760)Dimension Diagnostics1985-01-08
GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 (K844018)United Diagnostics, Inc.1984-11-27
STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 (K843986)United Diagnostics, Inc.1984-11-27
QUALIFY I & II AMER. MONITOR 2009 & 2010 (K843611)American Monitor Corp.1984-09-28
ALLERGENTICS TOTAL IGE/THEOPHYLLINE (K842970)Allergenetics1984-08-29
KODAK EKTACHEM CONTROL (K841884)Eastman Kodak Company1984-07-06
NOVA STAT CONTROL LEVELS 1/2/3 (K841452)Nova Biomedical Corp.1984-06-22
BIOTIS ABNORMAL CLINICAL CHEM SERUM- (K840458)Otisville Biotech, Inc.1984-04-17
NORMAL CLINICAL CHEM. CONTROL SERUM- (K840457)Otisville Biotech, Inc.1984-04-13
ORTHO BI-LEVEL RECEPTOR CONTROL (K834064)Ortho Diagnostic Systems, Inc.1984-03-23
OMNI-FAL I & II (K833009)American Monitor Corp.1984-01-13
TITANGEL HIGH RESOLUTION CONTROL (K833639)Helena Laboratories1984-01-04
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