Panels › Clinical Chemistry › Product code JLW · Class 2
Radioimmunoassay, Thyroid-Stimulating Hormone
Regulation 862.1690
1510(k)s in 12 months (242 all time)
1recalls in 12 months (46 all time)
44recalls that name a 510(k)
Top companies in JLW
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 30, 1991 | K910981 | CIBA CORNING ACS TSH IMMUNOASSAY Ciba Corning Diagnostics Corp. | JLW |
| Apr 3, 1991 | K910411 | MICROZYME TSH ENZYME IMMUNOASSAY KIT Immunotech Corp. | JLW |
| Feb 22, 1991 | K910256 | ECLIPSE ICA TSH Biotope, Inc. | JLW |
| Feb 21, 1991 | K905710 | PHARMACIA DELFIA NEONATAL HTSH KIT Pharmacia, Inc. | JLW |
| Jan 31, 1991 | K905769 | IMMULITE HS-TSH Cirrus Diagnostics, Inc. | JLW |
| Dec 18, 1990 | K905099 | ELEGANCE TSH ELISA Bioclone Australia Pty , Ltd. | JLW |
| Nov 2, 1990 | K904666 | AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 Amersham Corp. | JLW |
| Oct 26, 1990 | K903725 | EZ-BEAD TSH ENZYME IMMUNOASSAY KIT Immunotech Corp. | JLW |
| Oct 12, 1990 | K903391 | ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM Nichols Institute | JLW |
| Sep 7, 1990 | K903311 | NOVAPATH TSH ENZYME IMMUNOASSAY Bio-Rad | JLW |
| Jul 10, 1990 | K902753 | IMX ULTRASENTITIVE HTSH Abbott Mfg., Inc. | JLW |
| Jul 5, 1990 | K902333 | OPUS TSH TEST SYSTEM Pb Diagnostic Systems, Inc. | JLW |
| Apr 11, 1990 | K900277 | ENZYMUN TEST(R) TSH-S Boehringer Mannheim Corp. | JLW |
| Mar 9, 1990 | K897138 | AFFINITY(TM) HTSH(TM) Bd Becton Dickinson Vacutainer Systems Preanalytic | JLW |
| Feb 23, 1990 | K896867 | THYROID STIMULATING HORMONE-EIA-XT In Vitro Diagnostics, Inc. | JLW |
| Jan 19, 1990 | K900014 | MILENIA (TM) TSH Diagnostic Products Corp. | JLW |
| Oct 31, 1989 | K895396 | CYBERFLUOR FIAGEN TSH Cyberfluor, Inc., CA | JLW |
| Mar 28, 1989 | K890802 | COTUBE(TM) TSH IRMA Bio-Rad | JLW |
| Mar 16, 1989 | K890579 | TSH MICROASSAY Diamedix Corp. | JLW |
| Feb 10, 1989 | K885157 | VENTREX COATED TUBE HIGH SENSITIVITY TSH Ventrex Laboratories, Inc. | JLW |
| Jan 3, 1989 | K883742 | MODIFIED TSH IRMA KIT Pacific Biotech, Inc. | JLW |
| Dec 15, 1988 | K883726 | THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL Immuchem Corp. | JLW |
| Oct 3, 1988 | K881627 | DELFIA(TM) NEONATAL HTSH KIT Pharmacia, Inc. | JLW |
| Sep 22, 1988 | K882907 | AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT Amersham Corp. | JLW |
| Sep 13, 1988 | K883342 | VENTREX COATED TUBE TSH Ventrex Laboratories, Inc. | JLW |
| Jul 21, 1988 | K881381 | REAGENTS FOR TSH ASSAY Sclavo, Inc. | JLW |
| May 27, 1988 | K881443 | LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY London Diagnostics, Inc. | JLW |
| Apr 5, 1988 | K880086 | ABBOTT IMX HTSH Abbott Laboratories | JLW |
| Dec 18, 1987 | K874622 | FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301 Cyberfluor, Inc., CA | JLW |
| Nov 3, 1987 | K874061 | TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093 Medix Biotech, Inc. | JLW |
| Oct 2, 1987 | K873303 | BINAX L.S. TSH IRMA TEST KIT Binax, Inc. | JLW |
| Jul 31, 1987 | K872897 | TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA. Serono Diagnostics, Inc. | JLW |
| Jul 1, 1987 | K872305 | IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX Diagnostic Products Corp. | JLW |
| May 26, 1987 | K871505 | AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT Micromedic Systems | JLW |
| May 26, 1987 | K870904 | MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT Micromedic Systems | JLW |
| May 12, 1987 | K871644 | DELFIA (TM) HTSH KIT Lkb Instruments, Inc. | JLW |
| Apr 1, 1987 | K870245 | AUTOPAK TSH MONOCLONAL IRMA KIT Micromedic Systems | JLW |
| Apr 1, 1987 | K870244 | IQ TSH IMMUNOASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic | JLW |
| Mar 17, 1987 | K870320 | DACOMED PENILE PROSTHESIS SIZER Dacomed Corp. | JLW |
| Mar 13, 1987 | K865071 | THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT Immuchem Corp. | JLW |
| Mar 12, 1987 | K865081 | AFFINITY(TM) HTSH IMMUNIT(TM) Bd Becton Dickinson Vacutainer Systems Preanalytic | JLW |
| Feb 4, 1987 | K864839 | TSH MAB IRMA Bd Becton Dickinson Vacutainer Systems Preanalytic | JLW |
| Feb 4, 1987 | K864659 | BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH Bio Mega Diagnostic, Inc., CA | JLW |
| Jan 7, 1987 | K864677 | TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP Serono Diagnostics, Inc. | JLW |
| Dec 18, 1986 | K864133 | DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT Diagnostic Systems Laboratories, Inc. | JLW |
| Dec 16, 1986 | K864134 | DSL-4800 ACTIVE TM TSH EIA SYSTEM Diagnostic Systems Laboratories, Inc. | JLW |
| Dec 16, 1986 | K864079 | UBI MAGIWEL(TM) TSH QUANTITATIVE United Biotech, Inc. | JLW |
| Nov 21, 1986 | K863859 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM Hybritech, Inc. | JLW |
| Aug 29, 1986 | K862407 | CIBA CORNING MAGIC LITE TSH IMMUNOASSAY Ciba Corning Diagnostics Corp. | JLW |
| Aug 19, 1986 | K862428 | STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY American Dade | JLW |
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