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JJY

673 FDA 510(k) clearances · Product code

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RecordFirmDate
NORMAL URINE CONTROL (K833192)Biosan Laboratories, Inc.1983-12-08
ABNORMAL URINE CONTROL (K833191)Biosan Laboratories, Inc.1983-12-08
VENTREZYME EIA CONTROLS-IMMUNOASSAY (K833423)Ventrex Laboratories, Inc.1983-12-08
ELECTROPHORESIS CONTROLS-3 IN 1 (K831263)Corning Medical & Scientific1983-07-07
BIOCELL SPINAL FLUID CONTROL (K830179)Biocell Laboratories, Inc.1983-02-18
IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS (K823352)American Dade1983-02-07
MULTIANALYTE CONTROLS-ALL KINDS (K823929)Fisher Scientific Co., LLC1983-01-28
ORTHO BI-LEVEL ASSAYED LIPID PROFILE (K823490)Ortho Diagnostic Systems, Inc.1983-01-05
MONI-TRO ES CHEMISTRY CONTROL LEVEL IX (K822850)American Dade1982-10-27
TITAN GEL SERUM CONTROL (K821982)Helena Laboratories1982-08-16
BI-LEVEL ASSAYED TUMOR MARKER & ANTIN (K821026)Ortho Diagnostic Systems, Inc.1982-08-10
IGE/THE OPHYLLINE CONTROL SERUM I,II,III (K822133)Kallestad Laboratories, Inc.1982-08-03
LEVEL II LIPID CONTROL (K821560)Irvine Scientific1982-07-13
LEVEL I LIPID CONTROL (K821559)Irvine Scientific1982-07-13
LEVEL I CONTROL SERUM (K821557)Irvine Scientific1982-07-08
CHEMISTRY CONTROL/STANDARD (K821382)Medical Analysis Systems, Inc.1982-05-28
RESPONSE LIQUID LIGAND ASSAY SERUM (K821242)Beckman Instruments, Inc.1982-05-21
BI-LEVEL ASSAYED URINE METAL CONTROL (K820255)Ortho Diagnostic Systems, Inc.1982-02-18
Q-LINE LTC (K813580)Miles Laboratories, Inc.1982-01-18
ORTHO CO2 DILUENT LEVEL I (K813293)Ortho Diagnostic Systems, Inc.1981-12-17
ORTHO* UNASSAYED CONTROL SERUM LEVEL I (K813321)Ortho Diagnostic Systems, Inc.1981-12-17
ORTHO CO2 DILUENT LEVEL II (K813294)Ortho Diagnostic Systems, Inc.1981-12-17
ORTHO CO2 DILUENT LEVEL III (K813295)Ortho Diagnostic Systems, Inc.1981-12-17
ORTHO* UNASSAYED CONTROL SERUM LEVEL III (K813322)Ortho Diagnostic Systems, Inc.1981-12-17
ORTHO UNASSAYED CONTROL SERUM LEVEL II (K813167)Ortho Diagnostic Systems, Inc.1981-11-24
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C (K812556)American Dade1981-11-02
BECKMAN ICS NORMAL CONTROL SERA (K812650)Beckman Instruments, Inc.1981-10-19
ANEMIA CONTROL (K812635)Environmental Chemical Specialties1981-10-02
BOVINE CHEMISTRY CONTROL I.X. & II.X. (K812583)American Dade1981-09-24
HELENA FETAL-TEK 200 MARKER (K811695)Helena Laboratories1981-07-01
AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM (K811466)Ortho Diagnostic Systems, Inc.1981-06-12
IMIPRAMINE/DISIPRAMINE/LITHIUM (K811465)Ortho Diagnostic Systems, Inc.1981-06-12
DOXEPIN/DESMETHLDOXEPIN/LITHIUM (K811467)Ortho Diagnostic Systems, Inc.1981-06-12
MULTIANALYTE CONTROLS, ALL KINDS (K811182)Fisher Scientific Co., LLC1981-05-15
GELMAN ELECTROPHORESIS CONTROL (K811100)Gelman Sciences, Inc.1981-05-01
CORNING VITAMIN B12 FOLATE DEFIC. CONTR. (K810952)Corning Medical & Scientific1981-04-17
TRI-LEVEL NDI CONTROL (K810906)Nuclear Diagnostics, Inc.1981-04-14
TRI-LEVEL RADIOASSAY CONTROL SERA (K803098)American Diagnostic Corp.1981-01-09
CHEM-ASSAY STANDARD-CONTROLS (K802962)National Bio-Technical Laboratories1980-12-22
KEMTROL SERUM CONTROL-NORMAL (K802108)Helena Laboratories1980-10-10
KEMTROL SERUM CONTROL ABNORMAL (K802109)Helena Laboratories1980-10-10
ASSURE LEVEL I PROD. #30171 (K801538)Warner-Lambert Co.1980-09-09
ASSURE LEVEL II PROD. #30172 (K801539)Warner-Lambert Co.1980-09-09
UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE (K801335)Warner-Lambert Co.1980-07-08
DIAGNOSTIC PRODUCTS CORP. RIA CONTROL (K800813)Diagnostic Products Corp.1980-04-24
SERTROL PRODUCT # ACS ST 101 (K800559)Analytical Control Systems, Inc.1980-03-25
LIPID CONTROL PRODUCT # ACS LC 101 (K800558)Analytical Control Systems, Inc.1980-03-25
CK/LD ISOENZYME CONTROL PROD. #ACS CT101 (K800370)Analytical Control Systems, Inc.1980-03-12
ELEVATED LIPID CONTROL (K792375)Environmental Chemical Specialties1979-12-06
LYOPHILIZED HDL CHOLESTEROL CONTROLS (K792025)Helena Laboratories1979-10-30
LIPOTROL (K792024)Helena Laboratories1979-10-30
SERACON - EL DO27 (K791958)Bhp Diagnostix, Inc.1979-10-17
LY-PRO-TROL #ACS-LP101 (K791825)Analytical Control Systems, Inc.1979-10-01
CONTRO I (K791695)Hi Chem, Inc.1979-09-24
CONTRO II (K791696)Hi Chem, Inc.1979-09-24
NORMAL CONTROL (K791654)Electrophoresis Corp. of America1979-09-17
ARS, CHEMISTRY (K791313)Mid Tech, Inc.1979-08-16
MACOMB NORMAL CONTROL SERUM (K791119)Macomb Chemical Co.1979-07-30
THYROID CONTROL SERA CODE QAS.101 (K790840)Amersham Corp.1979-06-28
MACOMB LIPID CONTROL (K790371)Macomb Chemical Co.1979-04-04
DATA-TOPE TRI-RAC RADIOASSAY CONTROL (K790264)Dade, Baxter Travenol Diagnostics, Inc.1979-03-21
CALBIOCHEM-BEHRING LASER IMMUNOGLOBULIN (K790330)Calbiochem-Behring Corp.1979-03-15
SERACON-C (K782038)Bhp Diagnostix, Inc.1979-02-08
CONTROL, PROTEIN ELECTROPHORESIS (K781893)Sigma Chemical Co.1978-12-20
RIA CONTROLS (K781593)Dade, Baxter Travenol Diagnostics, Inc.1978-10-17
COMP. CLIN. CHEM. CONTROL SERUM-DECISION (K780552)Beckman Instruments, Inc.1978-05-19
NORMAL UNASSAYED CONTROL SERA (K780351)Macomb Chemical Co.1978-04-24
LDH ISOENZYME CONTROL SERUM (K780096)Worthington Biochemical Corp.1978-03-03
SERONORM LIPID (K771437)Nyegaard & Co. A/S1977-09-02
CHEMISTRY CONTROL-LOW & HIGH TQC TM (K770380)Technicon Instruments Corp.1977-04-15
CHEMISTRY CONTROL, NORMAL (K770310)Icn Pharmaceuticals, Inc.1977-04-05
CHEMISTRY CONTROL, ABNORMAL (K770312)Icn Pharmaceuticals, Inc.1977-04-05
TRIS BICARBONATE DILUENT (K760818)Hyland Therapeutic Div., Travenol Laboratories1976-11-05
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