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JLW

242 FDA 510(k) clearances · Product code

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RecordFirmDate
CIBA CORNING ACS TSH IMMUNOASSAY (K910981)Ciba Corning Diagnostics Corp.1991-04-30
MICROZYME TSH ENZYME IMMUNOASSAY KIT (K910411)Immunotech Corp.1991-04-03
ECLIPSE ICA TSH (K910256)Biotope, Inc.1991-02-22
PHARMACIA DELFIA NEONATAL HTSH KIT (K905710)Pharmacia, Inc.1991-02-21
IMMULITE HS-TSH (K905769)Cirrus Diagnostics, Inc.1991-01-31
ELEGANCE TSH ELISA (K905099)Bioclone Australia Pty , Ltd.1990-12-18
AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 (K904666)Amersham Corp.1990-11-02
EZ-BEAD TSH ENZYME IMMUNOASSAY KIT (K903725)Immunotech Corp.1990-10-26
ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM (K903391)Nichols Institute1990-10-12
NOVAPATH TSH ENZYME IMMUNOASSAY (K903311)Bio-Rad1990-09-07
IMX ULTRASENTITIVE HTSH (K902753)Abbott Mfg., Inc.1990-07-10
OPUS TSH TEST SYSTEM (K902333)Pb Diagnostic Systems, Inc.1990-07-05
ENZYMUN TEST(R) TSH-S (K900277)Boehringer Mannheim Corp.1990-04-11
AFFINITY(TM) HTSH(TM) (K897138)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-03-09
THYROID STIMULATING HORMONE-EIA-XT (K896867)In Vitro Diagnostics, Inc.1990-02-23
MILENIA (TM) TSH (K900014)Diagnostic Products Corp.1990-01-19
CYBERFLUOR FIAGEN TSH (K895396)Cyberfluor, Inc.1989-10-31
COTUBE(TM) TSH IRMA (K890802)Bio-Rad1989-03-28
TSH MICROASSAY (K890579)Diamedix Corp.1989-03-16
VENTREX COATED TUBE HIGH SENSITIVITY TSH (K885157)Ventrex Laboratories, Inc.1989-02-10
MODIFIED TSH IRMA KIT (K883742)Pacific Biotech, Inc.1989-01-03
THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL (K883726)Immuchem Corp.1988-12-15
DELFIA(TM) NEONATAL HTSH KIT (K881627)Pharmacia, Inc.1988-10-03
AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT (K882907)Amersham Corp.1988-09-22
VENTREX COATED TUBE TSH (K883342)Ventrex Laboratories, Inc.1988-09-13
REAGENTS FOR TSH ASSAY (K881381)Sclavo, Inc.1988-07-21
LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY (K881443)London Diagnostics, Inc.1988-05-27
ABBOTT IMX HTSH (K880086)Abbott Laboratories1988-04-05
FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301 (K874622)Cyberfluor, Inc.1987-12-18
TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093 (K874061)Medix Biotech, Inc.1987-11-03
BINAX L.S. TSH IRMA TEST KIT (K873303)Binax, Inc.1987-10-02
TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA. (K872897)Serono Diagnostics, Inc.1987-07-31
IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX (K872305)Diagnostic Products Corp.1987-07-01
AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT (K871505)Micromedic Systems1987-05-26
MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT (K870904)Micromedic Systems1987-05-26
DELFIA (TM) HTSH KIT (K871644)Lkb Instruments, Inc.1987-05-12
AUTOPAK TSH MONOCLONAL IRMA KIT (K870245)Micromedic Systems1987-04-01
IQ TSH IMMUNOASSAY (K870244)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-04-01
DACOMED PENILE PROSTHESIS SIZER (K870320)Dacomed Corp.1987-03-17
THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT (K865071)Immuchem Corp.1987-03-13
AFFINITY(TM) HTSH IMMUNIT(TM) (K865081)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-12
BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH (K864659)Bio Mega Diagnostic, Inc.1987-02-04
TSH MAB IRMA (K864839)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-02-04
TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP (K864677)Serono Diagnostics, Inc.1987-01-07
DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT (K864133)Diagnostic Systems Laboratories, Inc.1986-12-18
UBI MAGIWEL(TM) TSH QUANTITATIVE (K864079)United Biotech, Inc.1986-12-16
DSL-4800 ACTIVE TM TSH EIA SYSTEM (K864134)Diagnostic Systems Laboratories, Inc.1986-12-16
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM (K863859)Hybritech, Inc.1986-11-21
CIBA CORNING MAGIC LITE TSH IMMUNOASSAY (K862407)Ciba Corning Diagnostics Corp.1986-08-29
STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY (K862428)American Dade1986-08-19
MICROMEDIC HTSH MONOCLONAL IRMA KIT (K860813)Micromedic Systems1986-07-14
V-TREND EIA TSH (K861918)V-Tech, Inc.1986-07-02
TSH IRMA KIT (K862249)Pacific Biotech, Inc.1986-06-27
TERUMO SENSIBEAD EIA TSH KIT (K861573)Terumo Medical Corp.1986-06-19
SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO. (K861920)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-06-16
TSHK-NN RIA KIT (K860824)Cis-Us, Inc.1986-04-28
ECHOCLONAL HTSH IRMA (K860288)Bio-Rad1986-04-11
TSH-IRMA COAT-A-COUNT KIT (K860054)Diagnostic Products Corp.1986-03-17
MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT (K854379)Bioclinical Systems, Inc.1986-01-07
NML TSH IRMA (K854087)Organon Teknika Corp.1985-10-25
BETA-TSH-IRMA (K853977)Leeco Diagnostics, Inc.1985-10-22
ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM (K853717)Nichols Institute Diagnostics1985-10-02
NML TSH IRMA (K852438)Nuclear Medical Laboratories, Inc.1985-07-12
LEE-BEAD TSH(EIA) (K852224)Lecco Diagnostics, Inc.1985-07-09
MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA (K851329)Corning Medical & Scientific1985-06-13
DELFIA HTSH KIT (K851120)Lkb Instruments, Inc.1985-05-31
ENDAB TSH (K851980)Immunotech Corp.1985-05-31
TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE (K851148)Euro-Diagnostics BV1985-04-29
TSH-STAT (K844583)Nuclear Medical Laboratories, Inc.1985-03-05
TERUMO SENSIBEAD EIA TSH KIT (K850376)Terumo Medical Corp.1985-03-04
ABBOTT HTSH EIA DIAGNOSTIC KIT (K843540)Abbott Laboratories1984-11-02
ENCORE TSH REAGENT (K843395)Hybritech, Inc.1984-10-11
TSH QUIK RIA KIT (K843545)Pacific Biotech, Inc.1984-10-02
ACCUSCREEN TSH (K843281)Neometrics, Inc.1984-09-26
SUCROSEP THYROID STIMULATING HORMONE (K842593)Boots-Celltech Diagnostics, Inc.1984-09-12
AMERLEX-M TSH RIA (K842948)Amersham Corp.1984-09-04
BLOOD SPOT NEONATAL TSH RADIOIMMUNO (K841606)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-05-22
BIODEX ACT-O-KIT TSH-RIA- (K840088)Biodan Medical Systems, Ltd.1984-05-07
RADIOIMMUNOASSAY, THYROID STIMU. HORMONE (K833193)Biosan Laboratories, Inc.1984-02-04
SERUM THYROTROPIN ASSAY KIT, TIPSEP- (K833713)Nuclear Diagnostics, Inc.1983-12-29
TANDEM-E THYROID STIMULATING HORMONE KIT (K832813)Hybritech, Inc.1983-10-31
ENZYMUNE-TEST TSH (K832823)Icl Scientific1983-10-14
EPSILON TSH TEST KIT (K831972)Beckman Instruments, Inc.1983-09-20
AUTOPAK NEONATAL TSH RIA KIT (K832462)Micromedic Systems1983-09-12
PHASE II TSH KIT (K832499)Medical & Scientific Designs, Inc.1983-09-12
MAGIC TSH 125I RADIOIMMUNOASSAY (K832313)Corning Medical & Scientific1983-09-01
VENTREX ENZYME TSH KIT (K830928)Ventrex Laboratories, Inc.1983-04-28
NEONATAL NTSH RADIOIMMUNOASSAY SYS (K830036)Corning Medical & Scientific1983-01-28
DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO (K823688)Corning Medical & Scientific1983-01-05
THYROID STIMULATING HORMONE (K822935)Pcl-Ria, Inc.1982-11-01
HISH EIA DIAGNOSTIC KIT (K822827)Abbott Laboratories1982-10-27
TAMDEM-R THYROID STIMULATING HORMONE KIT (K822705)Hybritech, Inc.1982-10-13
QUANTIMUNE HTSH IRMA (K822291)Bio-Rad1982-08-27
(125I) HTSH RADIOIMMUNOASSAY KIT (K821620)Yang Laboratories, Inc.1982-06-14
TSH-SQUIBB RADIOIMMUNOASSAY KIT (K821174)Squibb & Sons, Inc.1982-05-14
TSH (RIA) KIT (K820089)Immuno Assay Corp.1982-01-28
MICROMEDIC HTSH RIA KIT (K813645)Micromedic Systems1982-01-22
IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY (K813525)Micromedic Systems1981-12-31
RADIOIMMUNOASSAY FOR HUMAN THYROID (K813392)Leeco Diagnostics, Inc.1981-12-22
AMERLEX TSH RIA KIT (K812136)Amersham Corp.1981-08-13
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