Panels › Clinical Chemistry › Product code CEW · Class 2
Radioimmunoassay, Parathyroid Hormone
Regulation 862.1545
0510(k)s in 12 months (86 all time)
0recalls in 12 months (21 all time)
20recalls that name a 510(k)
Top companies in CEW
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 22, 2024 | K231927 | Elecsys PTH , Elecsys PTH STAT Roche Diagnostics | CEW |
| Mar 1, 2024 | K232791 | Access Intact PTH Beckman Coulter, Inc. | CEW |
| Sep 5, 2023 | K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack Ortho Clinical Diagnostics, GB | CEW |
| Aug 30, 2019 | K190702 | Lumipulse G whole PTH Fujirebio Diagnostics,Inc. | CEW |
| May 23, 2017 | K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay Siemens Healthcare Diagnostics, Inc. | CEW |
| Jan 31, 2017 | K161158 | IDS-iSYS Intact PTHN Immunodiagnostic Systems , Ltd., GB | CEW |
| Jun 22, 2015 | K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers DiaSorin, Inc. | CEW |
| Feb 5, 2014 | K133601 | ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY Siemens Healthcare Diagnostics, Inc. | CEW |
| Nov 8, 2013 | K132515 | LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS DiaSorin, Inc. | CEW |
| Mar 21, 2013 | K121981 | ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY Siemens Healthcare Diagnostics | CEW |
| Feb 3, 2012 | K103325 | IDS-ISYS INTACT PTH Immunodiagnostic Systems , Ltd., GB | CEW |
| Oct 22, 2010 | K101921 | VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT Ortho-Clinical Diagnostics | CEW |
| Jul 13, 2007 | K070709 | ROCHE ELECSYS PTH TEST SYSTEM Roche Diagnostics Corp. | CEW |
| Jun 21, 2007 | K063605 | ST AIA-PACK INTACT PTH ASSAY Tosoh Bioscience, Inc. | CEW |
| Jun 19, 2007 | K063232 | ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 Biokit, S.A., ES | CEW |
| Mar 20, 2007 | K070391 | ELECSYS PTH TEST SYSTEM Roche Diagnostics Corp. | CEW |
| Sep 15, 2006 | K061190 | ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 Beckman Coulter, Inc. | CEW |
| Mar 1, 2006 | K060420 | MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 Scantibodies Laboratory, Inc. | CEW |
| Feb 27, 2006 | K060348 | MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT Scantibodies Laboratory, Inc. | CEW |
| Feb 3, 2006 | K053533 | IMMULITE/IMMULITE 1000 TURBO INTACT PTH Diagnostic Products Corporation | CEW |
| Oct 18, 2005 | K051888 | TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 Scantibodies Laboratory, Inc. | CEW |
| Sep 9, 2005 | K051810 | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 Scantibodies Laboratory, Inc. | CEW |
| Jul 26, 2005 | K051150 | TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT Scantibodies Laboratory, Inc. | CEW |
| Jul 26, 2005 | K051141 | WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 Scantibodies Laboratory, Inc. | CEW |
| Jun 8, 2004 | K040813 | NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 Nichols Institute Diagnostics | CEW |
| Apr 22, 2004 | K033727 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY Nichols Institute Diagnostics | CEW |
| Feb 12, 2004 | K033426 | LIAISON N-TACT PTH DiaSorin, Inc. | CEW |
| Jan 26, 2004 | K033302 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 Nichols Institute Diagnostics | CEW |
| Jul 30, 2003 | K031534 | CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 Scantibodies Laboratory, Inc. | CEW |
| Oct 9, 2002 | K022472 | PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) Nichols Institute Diagnostics | CEW |
| Aug 21, 2002 | K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER Diagnostic Products Corp. | CEW |
| May 31, 2002 | K020945 | AXSYM INTACT PTH, MODEL 2G06 Diagnostic Systems Laboratories, Inc. | CEW |
| Dec 13, 2001 | K013992 | NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY Nichols Institute Diagnostics | CEW |
| Nov 20, 2001 | K013566 | IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 Diagnostic Products Corp. | CEW |
| Jul 2, 2001 | K011505 | IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 Diagnostic Products Corp. | CEW |
| Apr 30, 2001 | K004038 | TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 Scantibodies Laboratory, Inc. | CEW |
| Aug 21, 2000 | K001411 | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056 Scantibodies Laboratory, Inc. | CEW |
| Apr 11, 2000 | K000471 | FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT Future Diagnostics B.V. | CEW |
| Sep 28, 1999 | K992680 | ELECSYS PARATHYROID HORMONE TEST SYSTEM Roche Diagnostics Corp. | CEW |
| Jul 6, 1999 | K992105 | IMMULITE TURBO INTACT PTH, MODEL LSKPTZ Diagnostic Products Corp. | CEW |
| Dec 23, 1997 | K974306 | SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA Sangui Biotech, Inc. | CEW |
| Oct 31, 1997 | K973514 | ACTIVE INTACT PTH Diagnostic Systems Laboratories, Inc. | CEW |
| Apr 14, 1997 | K970483 | AQUALITE INTACT PTH Sealite Sciences, Inc. | CEW |
| Dec 10, 1996 | K962598 | NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT Nichols Institute Diagnostics | CEW |
| Sep 27, 1996 | K962033 | CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT Nichols Institute Diagnostics | CEW |
| Nov 3, 1995 | K954418 | INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) Nichols Institute Diagnostics | CEW |
| Jul 19, 1995 | K944788 | INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY) Scantibodies Laboratory, Inc. | CEW |
| Jul 17, 1995 | K952199 | ACTIVE INTACT PTH ELISA Diagnostic Systems Laboratories, Inc. | CEW |
| Apr 13, 1995 | K950211 | ELSA-PTH Cis-Us, Inc. | CEW |
| Sep 20, 1994 | K942369 | GAMMA-BCT INTACT PTH Immunodiagnostic Systems , Ltd., GB | CEW |
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