FDA Product Code
FDA Product Code CEW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1545
510(k) Clearances — 86 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231927 | Elecsys PTH , Elecsys PTH STAT | Roche Diagnostics | 2024-03-22 | Traditional | PDF ↗ |
| K232791 | Access Intact PTH | Beckman Coulter, Inc. | 2024-03-01 | Traditional | PDF ↗ |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | Ortho Clinical Diagnostics | 2023-09-05 | Traditional | PDF ↗ |
| K190702 | Lumipulse G whole PTH | Fujirebio Diagnostics,Inc. | 2019-08-30 | Traditional | PDF ↗ |
| K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay | Siemens Healthcare Diagnostics, Inc. | 2017-05-23 | Traditional | PDF ↗ |
| K161158 | IDS-iSYS Intact PTHN | Immunodiagnostic Systems , Ltd. | 2017-01-31 | Traditional | PDF ↗ |
| K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers | DiaSorin, Inc. | 2015-06-22 | Traditional | PDF ↗ |
| K133601 | ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY | Siemens Healthcare Diagnostics, Inc. | 2014-02-05 | Traditional | PDF ↗ |
| K132515 | LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS | DiaSorin, Inc. | 2013-11-08 | Traditional | PDF ↗ |
| K121981 | ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY | Siemens Healthcare Diagnostics | 2013-03-21 | Traditional | PDF ↗ |
| K103325 | IDS-ISYS INTACT PTH | Immunodiagnostic Systems , Ltd. | 2012-02-03 | Traditional | PDF ↗ |
| K101921 | VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT | Ortho-Clinical Diagnostics | 2010-10-22 | Traditional | PDF ↗ |
| K070709 | ROCHE ELECSYS PTH TEST SYSTEM | Roche Diagnostics Corp. | 2007-07-13 | Traditional | PDF ↗ |
| K063605 | ST AIA-PACK INTACT PTH ASSAY | Tosoh Bioscience, Inc. | 2007-06-21 | Traditional | PDF ↗ |
| K063232 | ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 | Biokit, S.A. | 2007-06-19 | Traditional | PDF ↗ |
| K070391 | ELECSYS PTH TEST SYSTEM | Roche Diagnostics Corp. | 2007-03-20 | Special | PDF ↗ |
| K061190 | ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 | Beckman Coulter, Inc. | 2006-09-15 | Traditional | PDF ↗ |
| K060420 | MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 | Scantibodies Laboratory, Inc. | 2006-03-01 | Special | PDF ↗ |
| K060348 | MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT | Scantibodies Laboratory, Inc. | 2006-02-27 | Special | PDF ↗ |
| K053533 | IMMULITE/IMMULITE 1000 TURBO INTACT PTH | Diagnostic Products Corporation | 2006-02-03 | Traditional | PDF ↗ |
| K051888 | TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 | Scantibodies Laboratory, Inc. | 2005-10-18 | Traditional | PDF ↗ |
| K051810 | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 | Scantibodies Laboratory, Inc. | 2005-09-09 | Traditional | PDF ↗ |
| K051141 | WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 | Scantibodies Laboratory, Inc. | 2005-07-26 | Traditional | PDF ↗ |
| K051150 | TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT | Scantibodies Laboratory, Inc. | 2005-07-26 | Traditional | PDF ↗ |
| K040813 | NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 | Nichols Institute Diagnostics | 2004-06-08 | Traditional | PDF ↗ |
| K033727 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY | Nichols Institute Diagnostics | 2004-04-22 | Traditional | PDF ↗ |
| K033426 | LIAISON N-TACT PTH | DiaSorin, Inc. | 2004-02-12 | Traditional | PDF ↗ |
| K033302 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 | Nichols Institute Diagnostics | 2004-01-26 | Special | PDF ↗ |
| K031534 | CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 | Scantibodies Laboratory, Inc. | 2003-07-30 | Traditional | PDF ↗ |
| K022472 | PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) | Nichols Institute Diagnostics | 2002-10-09 | Traditional | PDF ↗ |
| K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER | Diagnostic Products Corp. | 2002-08-21 | Special | PDF ↗ |
| K020945 | AXSYM INTACT PTH, MODEL 2G06 | Diagnostic Systems Laboratories, Inc. | 2002-05-31 | Traditional | PDF ↗ |
| K013992 | NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY | Nichols Institute Diagnostics | 2001-12-13 | Traditional | PDF ↗ |
| K013566 | IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 | Diagnostic Products Corp. | 2001-11-20 | Special | PDF ↗ |
| K011505 | IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 | Diagnostic Products Corp. | 2001-07-02 | Traditional | PDF ↗ |
| K004038 | TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 | Scantibodies Laboratory, Inc. | 2001-04-30 | Traditional | PDF ↗ |
| K001411 | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056 | Scantibodies Laboratory, Inc. | 2000-08-21 | Traditional | PDF ↗ |
| K000471 | FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT | Future Diagnostics B.V. | 2000-04-11 | Traditional | PDF ↗ |
| K992680 | ELECSYS PARATHYROID HORMONE TEST SYSTEM | Roche Diagnostics Corp. | 1999-09-28 | Traditional | PDF ↗ |
| K992105 | IMMULITE TURBO INTACT PTH, MODEL LSKPTZ | Diagnostic Products Corp. | 1999-07-06 | Special | PDF ↗ |
| K974306 | SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA | Sangui Biotech, Inc. | 1997-12-23 | Traditional | PDF ↗ |
| K973514 | ACTIVE INTACT PTH | Diagnostic Systems Laboratories, Inc. | 1997-10-31 | Traditional | PDF ↗ |
| K970483 | AQUALITE INTACT PTH | Sealite Sciences, Inc. | 1997-04-14 | Traditional | PDF ↗ |
| K962598 | NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT | Nichols Institute Diagnostics | 1996-12-10 | Traditional | PDF ↗ |
| K962033 | CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT | Nichols Institute Diagnostics | 1996-09-27 | Traditional | PDF ↗ |
| K954418 | INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) | Nichols Institute Diagnostics | 1995-11-03 | Traditional | PDF ↗ |
| K944788 | INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY) | Scantibodies Laboratory, Inc. | 1995-07-19 | Traditional | PDF ↗ |
| K952199 | ACTIVE INTACT PTH ELISA | Diagnostic Systems Laboratories, Inc. | 1995-07-17 | Traditional | PDF ↗ |
| K950211 | ELSA-PTH | Cis-Us, Inc. | 1995-04-13 | Traditional | PDF ↗ |
| K942369 | GAMMA-BCT INTACT PTH | Immunodiagnostic Systems , Ltd. | 1994-09-20 | Traditional | PDF ↗ |
| K941878 | OCTEIA INTACT PTH | I.D.S. | 1994-09-07 | Traditional | PDF ↗ |
| K934760 | IMMUNLITE INTACT PTH | Diagnostic Products Corp. | 1993-12-10 | Traditional | PDF ↗ |
| K930008 | COAT-A-COUNT INTACT PTH IRMA | Diagnostic Products Corp. | 1993-06-15 | Traditional | PDF ↗ |
| K921949 | COTUBE PTH IRMA | Bio-Rad | 1992-09-02 | Traditional | PDF ↗ |
| K921629 | N-TACT(R) PTH SP KIT | Incstar Corp. | 1992-05-14 | Traditional | PDF ↗ |
| K913434 | VENTREX COATED TUBE INTACT PTH | Ventrex Laboratories, Inc. | 1991-10-25 | Traditional | PDF ↗ |
| K903130 | LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY | London Diagnostics, Inc. | 1990-09-25 | Traditional | PDF ↗ |
| K901711 | PTH-MM II 125I RADIOIMMUNOASSAY (RIA) | Incstar Corp. | 1990-07-16 | Traditional | PDF ↗ |
| K896294 | DSL I-PTH (DSL #8000) | Diagnostic Systems Laboratories, Inc. | 1989-11-21 | Traditional | PDF ↗ |
| K882560 | CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1988-10-13 | Traditional | PDF ↗ |
| K874299 | N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA) | Incstar Corp. | 1987-11-23 | Traditional | PDF ↗ |
| K871970 | DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2 | Diagnostic Products Corp. | 1987-09-25 | Traditional | PDF ↗ |
| K861797 | ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY | Nichols Institute Diagnostics | 1986-07-22 | Traditional | PDF ↗ |
| K853784 | C-TERMINAL PTH RIA KIT | Diagnostic Systems Laboratories, Inc. | 1985-10-04 | Traditional | PDF ↗ |
| K844735 | PTH-RIA | Syncor Intl. Corp. | 1985-04-29 | Traditional | PDF ↗ |
| K850254 | PARATHYROID HORMONE RADIOIMMUNOASSAY KIT | Cambridge Medical Technology | 1985-04-03 | Traditional | PDF ↗ |
| K843871 | PARATHYROID HORMONE C-TERMINAL RIA KIT | Diagnostic Products Corp. | 1984-10-30 | Traditional | PDF ↗ |
| K843870 | PARATHYROID HORMONE MID-MOLECULE RIA-KIT | Diagnostic Products Corp. | 1984-10-30 | Traditional | PDF ↗ |
| K843685 | C-TERMINAL/MID-MOLECULE PARATHYROID - | Nichols Institute Diagnostics | 1984-10-11 | Traditional | PDF ↗ |
| K840379 | PARATHYROID HORMONE ANALYSIS PRODUCT | Nichols Institute Diagnostics | 1984-04-04 | Traditional | PDF ↗ |
| K833768 | C. PTH RADIOIMMUNOASSAY KIT-CPTHK | Sorin Biomedica, Fiat, USA, Inc. | 1983-12-29 | Traditional | PDF ↗ |
| K831470 | PTH MR | Ramco Laboratories, Inc. | 1983-06-22 | Traditional | PDF ↗ |
| K831069 | DAC-CEL PTH KIT RD51 | Wellcome Diagnostics | 1983-06-16 | Traditional | PDF ↗ |
| K830664 | HUMAN INTRACT PARATHYROID HORMONE BY | Immuno Nuclear Corp. | 1983-05-09 | Traditional | PDF ↗ |
| K830700 | MMH PTH RIA KIT | Diagnostic Systems | 1983-04-06 | Traditional | PDF ↗ |
| K822944 | GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT | Travenol Laboratories, S.A. | 1982-12-30 | Traditional | PDF ↗ |
| K821131 | RADIOIMMUNOASSAY PARATHYROID HORMONE MID | Endocrine-Metabolic Center | 1982-06-02 | Traditional | PDF ↗ |
| K820228 | MIN-MOLECULE PTH BY RADIOIMMUNOASSAY | Immuno Nuclear Corp. | 1982-03-11 | Traditional | PDF ↗ |
| K813203 | C-TERMINAL PTH RIA TEST KIT, DSL-1000 | Diagnostic Systems Laboratories, Inc. | 1981-12-03 | Traditional | PDF ↗ |
| K811566 | C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT | Immuno Nuclear Corp. | 1981-06-25 | Traditional | PDF ↗ |
| K811418 | N-TERMINAL HPTH BY RIA | Immuno Nuclear Corp. | 1981-06-24 | Traditional | PDF ↗ |
| K791128 | PTH RIA 200 | Institut National Des Radioelements | 1979-09-27 | Traditional | PDF ↗ |
| K782081 | RIA SYSTEM, PARATHYROID HORMONE | Iso-Tex Diagnostics | 1979-03-21 | Traditional | PDF ↗ |
| K782010 | HORMONE KIT, PARATHYROID | Nichols Institute Diagnostics | 1979-01-10 | Traditional | PDF ↗ |
| K772249 | COMPLEMENT C3 NEPHELOMETRIC ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | Traditional | PDF ↗ |
| K771783 | PTH RIA | Nichols Institute Diagnostics | 1977-10-14 | Traditional | PDF ↗ |
Product code CEW · Class II · Clinical Chemistry. Data: openFDA.