FDA Product Code
FDA Product Code JLW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1690
510(k) Clearances — 242 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K910981 | CIBA CORNING ACS TSH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-04-30 | Traditional | PDF ↗ |
| K910411 | MICROZYME TSH ENZYME IMMUNOASSAY KIT | Immunotech Corp. | 1991-04-03 | Traditional | PDF ↗ |
| K910256 | ECLIPSE ICA TSH | Biotope, Inc. | 1991-02-22 | Traditional | PDF ↗ |
| K905710 | PHARMACIA DELFIA NEONATAL HTSH KIT | Pharmacia, Inc. | 1991-02-21 | Traditional | PDF ↗ |
| K905769 | IMMULITE HS-TSH | Cirrus Diagnostics, Inc. | 1991-01-31 | Traditional | PDF ↗ |
| K905099 | ELEGANCE TSH ELISA | Bioclone Australia Pty , Ltd. | 1990-12-18 | Traditional | PDF ↗ |
| K904666 | AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 | Amersham Corp. | 1990-11-02 | Traditional | PDF ↗ |
| K903725 | EZ-BEAD TSH ENZYME IMMUNOASSAY KIT | Immunotech Corp. | 1990-10-26 | Traditional | PDF ↗ |
| K903391 | ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM | Nichols Institute | 1990-10-12 | Traditional | PDF ↗ |
| K903311 | NOVAPATH TSH ENZYME IMMUNOASSAY | Bio-Rad | 1990-09-07 | Traditional | PDF ↗ |
| K902753 | IMX ULTRASENTITIVE HTSH | Abbott Mfg., Inc. | 1990-07-10 | Traditional | PDF ↗ |
| K902333 | OPUS TSH TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-07-05 | Traditional | PDF ↗ |
| K900277 | ENZYMUN TEST(R) TSH-S | Boehringer Mannheim Corp. | 1990-04-11 | Traditional | PDF ↗ |
| K897138 | AFFINITY(TM) HTSH(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-03-09 | Traditional | PDF ↗ |
| K896867 | THYROID STIMULATING HORMONE-EIA-XT | In Vitro Diagnostics, Inc. | 1990-02-23 | Traditional | PDF ↗ |
| K900014 | MILENIA (TM) TSH | Diagnostic Products Corp. | 1990-01-19 | Traditional | PDF ↗ |
| K895396 | CYBERFLUOR FIAGEN TSH | Cyberfluor, Inc. | 1989-10-31 | Traditional | PDF ↗ |
| K890802 | COTUBE(TM) TSH IRMA | Bio-Rad | 1989-03-28 | Traditional | PDF ↗ |
| K890579 | TSH MICROASSAY | Diamedix Corp. | 1989-03-16 | Traditional | PDF ↗ |
| K885157 | VENTREX COATED TUBE HIGH SENSITIVITY TSH | Ventrex Laboratories, Inc. | 1989-02-10 | Traditional | PDF ↗ |
| K883742 | MODIFIED TSH IRMA KIT | Pacific Biotech, Inc. | 1989-01-03 | Traditional | PDF ↗ |
| K883726 | THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL | Immuchem Corp. | 1988-12-15 | Traditional | PDF ↗ |
| K881627 | DELFIA(TM) NEONATAL HTSH KIT | Pharmacia, Inc. | 1988-10-03 | Traditional | PDF ↗ |
| K882907 | AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT | Amersham Corp. | 1988-09-22 | Traditional | PDF ↗ |
| K883342 | VENTREX COATED TUBE TSH | Ventrex Laboratories, Inc. | 1988-09-13 | Traditional | PDF ↗ |
| K881381 | REAGENTS FOR TSH ASSAY | Sclavo, Inc. | 1988-07-21 | Traditional | PDF ↗ |
| K881443 | LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY | London Diagnostics, Inc. | 1988-05-27 | Traditional | PDF ↗ |
| K880086 | ABBOTT IMX HTSH | Abbott Laboratories | 1988-04-05 | Traditional | PDF ↗ |
| K874622 | FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301 | Cyberfluor, Inc. | 1987-12-18 | Traditional | PDF ↗ |
| K874061 | TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093 | Medix Biotech, Inc. | 1987-11-03 | Traditional | PDF ↗ |
| K873303 | BINAX L.S. TSH IRMA TEST KIT | Binax, Inc. | 1987-10-02 | Traditional | PDF ↗ |
| K872897 | TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA. | Serono Diagnostics, Inc. | 1987-07-31 | Traditional | PDF ↗ |
| K872305 | IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX | Diagnostic Products Corp. | 1987-07-01 | Traditional | PDF ↗ |
| K871505 | AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT | Micromedic Systems | 1987-05-26 | Traditional | PDF ↗ |
| K870904 | MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT | Micromedic Systems | 1987-05-26 | Traditional | PDF ↗ |
| K871644 | DELFIA (TM) HTSH KIT | Lkb Instruments, Inc. | 1987-05-12 | Traditional | PDF ↗ |
| K870244 | IQ TSH IMMUNOASSAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-04-01 | Traditional | PDF ↗ |
| K870245 | AUTOPAK TSH MONOCLONAL IRMA KIT | Micromedic Systems | 1987-04-01 | Traditional | PDF ↗ |
| K870320 | DACOMED PENILE PROSTHESIS SIZER | Dacomed Corp. | 1987-03-17 | Traditional | PDF ↗ |
| K865071 | THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT | Immuchem Corp. | 1987-03-13 | Traditional | PDF ↗ |
| K865081 | AFFINITY(TM) HTSH IMMUNIT(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-03-12 | Traditional | PDF ↗ |
| K864839 | TSH MAB IRMA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-02-04 | Traditional | PDF ↗ |
| K864659 | BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH | Bio Mega Diagnostic, Inc. | 1987-02-04 | Traditional | PDF ↗ |
| K864677 | TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP | Serono Diagnostics, Inc. | 1987-01-07 | Traditional | PDF ↗ |
| K864133 | DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT | Diagnostic Systems Laboratories, Inc. | 1986-12-18 | Traditional | PDF ↗ |
| K864134 | DSL-4800 ACTIVE TM TSH EIA SYSTEM | Diagnostic Systems Laboratories, Inc. | 1986-12-16 | Traditional | PDF ↗ |
| K864079 | UBI MAGIWEL(TM) TSH QUANTITATIVE | United Biotech, Inc. | 1986-12-16 | Traditional | PDF ↗ |
| K863859 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM | Hybritech, Inc. | 1986-11-21 | Traditional | PDF ↗ |
| K862407 | CIBA CORNING MAGIC LITE TSH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1986-08-29 | Traditional | PDF ↗ |
| K862428 | STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | 1986-08-19 | Traditional | PDF ↗ |
| K860813 | MICROMEDIC HTSH MONOCLONAL IRMA KIT | Micromedic Systems | 1986-07-14 | Traditional | PDF ↗ |
| K861918 | V-TREND EIA TSH | V-Tech, Inc. | 1986-07-02 | Traditional | PDF ↗ |
| K862249 | TSH IRMA KIT | Pacific Biotech, Inc. | 1986-06-27 | Traditional | PDF ↗ |
| K861573 | TERUMO SENSIBEAD EIA TSH KIT | Terumo Medical Corp. | 1986-06-19 | Traditional | PDF ↗ |
| K861920 | SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO. | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-06-16 | Traditional | PDF ↗ |
| K860824 | TSHK-NN RIA KIT | Cis-Us, Inc. | 1986-04-28 | Traditional | PDF ↗ |
| K860288 | ECHOCLONAL HTSH IRMA | Bio-Rad | 1986-04-11 | Traditional | PDF ↗ |
| K860054 | TSH-IRMA COAT-A-COUNT KIT | Diagnostic Products Corp. | 1986-03-17 | Traditional | PDF ↗ |
| K854379 | MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT | Bioclinical Systems, Inc. | 1986-01-07 | Traditional | PDF ↗ |
| K854087 | NML TSH IRMA | Organon Teknika Corp. | 1985-10-25 | Traditional | PDF ↗ |
| K853977 | BETA-TSH-IRMA | Leeco Diagnostics, Inc. | 1985-10-22 | Traditional | PDF ↗ |
| K853717 | ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM | Nichols Institute Diagnostics | 1985-10-02 | Traditional | PDF ↗ |
| K852438 | NML TSH IRMA | Nuclear Medical Laboratories, Inc. | 1985-07-12 | Traditional | PDF ↗ |
| K852224 | LEE-BEAD TSH(EIA) | Lecco Diagnostics, Inc. | 1985-07-09 | Traditional | PDF ↗ |
| K851329 | MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA | Corning Medical & Scientific | 1985-06-13 | Traditional | PDF ↗ |
| K851120 | DELFIA HTSH KIT | Lkb Instruments, Inc. | 1985-05-31 | Traditional | PDF ↗ |
| K851980 | ENDAB TSH | Immunotech Corp. | 1985-05-31 | Traditional | PDF ↗ |
| K851148 | TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE | Euro-Diagnostics BV | 1985-04-29 | Traditional | PDF ↗ |
| K844583 | TSH-STAT | Nuclear Medical Laboratories, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K850376 | TERUMO SENSIBEAD EIA TSH KIT | Terumo Medical Corp. | 1985-03-04 | Traditional | PDF ↗ |
| K843540 | ABBOTT HTSH EIA DIAGNOSTIC KIT | Abbott Laboratories | 1984-11-02 | Traditional | PDF ↗ |
| K843395 | ENCORE TSH REAGENT | Hybritech, Inc. | 1984-10-11 | Traditional | PDF ↗ |
| K843545 | TSH QUIK RIA KIT | Pacific Biotech, Inc. | 1984-10-02 | Traditional | PDF ↗ |
| K843281 | ACCUSCREEN TSH | Neometrics, Inc. | 1984-09-26 | Traditional | PDF ↗ |
| K842593 | SUCROSEP THYROID STIMULATING HORMONE | Boots-Celltech Diagnostics, Inc. | 1984-09-12 | Traditional | PDF ↗ |
| K842948 | AMERLEX-M TSH RIA | Amersham Corp. | 1984-09-04 | Traditional | PDF ↗ |
| K841606 | BLOOD SPOT NEONATAL TSH RADIOIMMUNO | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-05-22 | Traditional | PDF ↗ |
| K840088 | BIODEX ACT-O-KIT TSH-RIA- | Biodan Medical Systems, Ltd. | 1984-05-07 | Traditional | PDF ↗ |
| K833193 | RADIOIMMUNOASSAY, THYROID STIMU. HORMONE | Biosan Laboratories, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K833713 | SERUM THYROTROPIN ASSAY KIT, TIPSEP- | Nuclear Diagnostics, Inc. | 1983-12-29 | Traditional | PDF ↗ |
| K832813 | TANDEM-E THYROID STIMULATING HORMONE KIT | Hybritech, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K832823 | ENZYMUNE-TEST TSH | Icl Scientific | 1983-10-14 | Traditional | PDF ↗ |
| K831972 | EPSILON TSH TEST KIT | Beckman Instruments, Inc. | 1983-09-20 | Traditional | PDF ↗ |
| K832462 | AUTOPAK NEONATAL TSH RIA KIT | Micromedic Systems | 1983-09-12 | Traditional | PDF ↗ |
| K832499 | PHASE II TSH KIT | Medical & Scientific Designs, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K832313 | MAGIC TSH 125I RADIOIMMUNOASSAY | Corning Medical & Scientific | 1983-09-01 | Traditional | PDF ↗ |
| K830928 | VENTREX ENZYME TSH KIT | Ventrex Laboratories, Inc. | 1983-04-28 | Traditional | PDF ↗ |
| K830036 | NEONATAL NTSH RADIOIMMUNOASSAY SYS | Corning Medical & Scientific | 1983-01-28 | Traditional | PDF ↗ |
| K823688 | DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO | Corning Medical & Scientific | 1983-01-05 | Traditional | PDF ↗ |
| K822935 | THYROID STIMULATING HORMONE | Pcl-Ria, Inc. | 1982-11-01 | Traditional | PDF ↗ |
| K822827 | HISH EIA DIAGNOSTIC KIT | Abbott Laboratories | 1982-10-27 | Traditional | PDF ↗ |
| K822705 | TAMDEM-R THYROID STIMULATING HORMONE KIT | Hybritech, Inc. | 1982-10-13 | Traditional | PDF ↗ |
| K822291 | QUANTIMUNE HTSH IRMA | Bio-Rad | 1982-08-27 | Traditional | PDF ↗ |
| K821620 | (125I) HTSH RADIOIMMUNOASSAY KIT | Yang Laboratories, Inc. | 1982-06-14 | Traditional | PDF ↗ |
| K821174 | TSH-SQUIBB RADIOIMMUNOASSAY KIT | Squibb & Sons, Inc. | 1982-05-14 | Traditional | PDF ↗ |
| K820089 | TSH (RIA) KIT | Immuno Assay Corp. | 1982-01-28 | Traditional | PDF ↗ |
| K813645 | MICROMEDIC HTSH RIA KIT | Micromedic Systems | 1982-01-22 | Traditional | PDF ↗ |
| K813525 | IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY | Micromedic Systems | 1981-12-31 | Traditional | PDF ↗ |
| K813392 | RADIOIMMUNOASSAY FOR HUMAN THYROID | Leeco Diagnostics, Inc. | 1981-12-22 | Traditional | PDF ↗ |
| K812136 | AMERLEX TSH RIA KIT | Amersham Corp. | 1981-08-13 | Traditional | PDF ↗ |
Product code JLW · Class II · Clinical Chemistry. Data: openFDA.