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 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K811558 | TSH-P.E.G. | Nuclear Diagnostics, Inc. | 1981-06-18 | Traditional | PDF ↗ |
| K811431 | TECHNICON STAR SYSTEM | Technicon Instruments Corp. | 1981-06-09 | Traditional | PDF ↗ |
| K810948 | RADIOIMMUNOASSAY THYROID STIM. HORM. KIT | Endocrine-Metabolic Center | 1981-04-17 | Traditional | PDF ↗ |
| K810213 | DAC-CEL TSH | Burroughs Wellcome Co. | 1981-02-10 | Traditional | PDF ↗ |
| K802467 | TSH RADIOIMMUNOASSAY KIT | American Diagnostic Corp. | 1980-10-31 | Traditional | PDF ↗ |
| K801691 | TSH RIASSAY | Ria Diagnostics | 1980-08-27 | Traditional | PDF ↗ |
| K801560 | VENTREX/SEP TSH TEST SET | Ventrex Laboratories, Inc. | 1980-08-13 | Traditional | PDF ↗ |
| K800798 | HUMAN THYROID STIM. HORMONE/ARIA II | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-04-24 | Traditional | PDF ↗ |
| K792562 | IMMUNOSTAT TSH TEST | Meloy Laboratories, Inc. | 1980-01-16 | Traditional | PDF ↗ |
| K792443 | TSH RADIOIMMUNOASSAY | Dade, Baxter Travenol Diagnostics, Inc. | 1979-12-27 | Traditional | PDF ↗ |
| K792154 | THYROID STIMULATING HORMONE | Radioimmunoassay, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K791747 | HTSH NEONATE RIA DIAGNOSTIC KIT | Abbott Laboratories | 1979-11-13 | Traditional | PDF ↗ |
| K791855 | CENTRIA TSH RIA | Union Carbide Corp. | 1979-10-17 | Traditional | PDF ↗ |
| K791301 | ORTHO TSH RIA KIT | Ortho Diagnostics, Inc. | 1979-09-24 | Traditional | PDF ↗ |
| K791217 | TSH RIA KIT | Antibodies, Inc. | 1979-09-04 | Traditional | PDF ↗ |
| K791065 | IMMUNOSPOT TSH TEST | Meloy Laboratories, Inc. | 1979-07-30 | Traditional | PDF ↗ |
| K790260 | NTSH AUTOPAK TEST DELIVERY SYSTEM | Micromedic Systems | 1979-03-21 | Traditional | PDF ↗ |
| K781953 | RIA KIT, IMMO PHASE | Corning Medical & Scientific | 1979-02-01 | Traditional | PDF ↗ |
| K781409 | IMMO PHASE, THYROID HORMONE | Corning Medical & Scientific | 1978-09-27 | Traditional | PDF ↗ |
| K781296 | THYRO-SHURE | Nuclear Medical Laboratories, Inc. | 1978-08-31 | Traditional | PDF ↗ |
| K781170 | QUANTIMUNE HTSH IRMA HUMAN THYROID | Bio-Rad | 1978-08-14 | Traditional | PDF ↗ |
| K781150 | RIA TSH IN HUMAN SERUM OR PLASMA | Diagnostic Corp. of America | 1978-07-27 | Traditional | PDF ↗ |
| K780726 | TSH RIA KIT | Amersham Corp. | 1978-06-13 | Traditional | PDF ↗ |
| K780428 | ROCHE TSH RIA | Hoffmann-La Roche, Inc. | 1978-03-30 | Traditional | PDF ↗ |
| K780059 | RABBIT ANTIBODY/THYROID STIMUL. HORMONE | Pcl-Ria, Inc. | 1978-02-13 | Traditional | PDF ↗ |
| K780015 | THYROID STIMULATING HORMONE | Pcl-Ria, Inc. | 1978-02-07 | Traditional | PDF ↗ |
| K772192 | NEONATAL TSH RIA KIT (125I) | Diagnostic Products Corp. | 1978-01-12 | Traditional | PDF ↗ |
| K772109 | IN VITRO HUMAN TSH RIA TEST | Clinical Assays, Inc. | 1977-12-06 | Traditional | PDF ↗ |
| K771767 | SERALUTE TSH (RIA) | Miles Laboratories, Inc. | 1977-10-25 | Traditional | PDF ↗ |
| K771378 | NEO TSH-RIA KIT | Nuclear Medical Systems, Inc. | 1977-10-18 | Traditional | PDF ↗ |
| K771234 | TSH RIA REAGENT SET | G.D. Searle and Co. | 1977-10-18 | Traditional | PDF ↗ |
| K771590 | THYROID STIMULATING HORMONE | New England Nuclear | 1977-09-15 | Traditional | PDF ↗ |
| K771377 | THYRODOT-4, THYRODOT-SH | Medcom Diagnostics, Inc. | 1977-09-02 | Traditional | PDF ↗ |
| K771222 | TSH RIA TEST SYSTEM | Monobind | 1977-08-04 | Traditional | PDF ↗ |
| K771235 | HTSH RIA HUMAN THYROID HORMONE RIA | Abbott Laboratories | 1977-08-03 | Traditional | PDF ↗ |
| K770915 | CLASP RIA KIT, HTSH | E. R. Squibb & Sons, Inc. | 1977-06-14 | Traditional | PDF ↗ |
| K770892 | TSH RADIOIMMUNOASSAY | Kallestad Laboratories, Inc. | 1977-06-14 | Traditional | PDF ↗ |
| K770604 | RIA-DAC TM HTSH KIH | Mallinckrodt Critical Care | 1977-04-06 | Traditional | PDF ↗ |
| K760255 | TEST SYSTEM, THYROID STIM. HORMONE ASSAY | Corning Medical & Scientific | 1976-11-19 | Traditional | PDF ↗ |
| K760801 | TSH RIA KIT | Diagnostic Products Corp. | 1976-11-01 | Traditional | PDF ↗ |
| K760044 | KIT, RIA, HUMAN THYROID HORMONE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-26 | Traditional | PDF ↗ |
| K760132 | TEST, RIA, TSH QUANTIMUNE | Bio-Rad | 1976-07-20 | Traditional | PDF ↗ |
Product code JLW · Class II · Clinical Chemistry. Data: openFDA.