Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040
FDA 510(k) K033302 · Nichols Institute Diagnostics
510(k) numberK033302
Submission
- Device name
- Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040
- Applicant
- Nichols Institute Diagnostics
San Clemente, CA, US - Received
- October 14, 2003
- Decision date
- January 26, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEW – Radioimmunoassay, Parathyroid Hormone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1545
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEW
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|---|---|---|---|
| K231927 | Elecsys PTH , Elecsys PTH STATCEW · Traditional | Roche Diagnostics | 03/22/2024SE |
| K232791 | Access Intact PTHCEW · Traditional | Beckman Coulter, Inc. | 03/01/2024SE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional | Ortho Clinical Diagnostics | 09/05/2023SE |
| K190702 | Lumipulse G whole PTHCEW · Traditional | Fujirebio Diagnostics,Inc. | 08/30/2019SE |
| K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) AssayCEW · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/23/2017SE |
| K161158 | IDS-iSYS Intact PTHNCEW · Traditional | Immunodiagnostic Systems , Ltd. | 01/31/2017SE |
| K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersCEW · Traditional | DiaSorin, Inc. | 06/22/2015SE |
| K133601 | Advia Centaur Intact Parathyroid Hormone (Ipth) AssayCEW · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/05/2014SE |
| K132515 | Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersCEW · Traditional | DiaSorin, Inc. | 11/08/2013SE |
| K121981 | Advia Centaur Inact Parathyroid Hormone (Ipth) AssayCEW · Traditional | Siemens Healthcare Diagnostics | 03/21/2013SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K050784 | Nichols Advantage Aldosterone AssayCJM · Traditional | 06/01/2005SE |
| K042676 | Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-Hcg) AssayDHA · Traditional | 12/17/2004SE |
| K042689 | Nichols Advantage CortisolCGR · Traditional | 12/09/2004SE |
| K040813 | Nichols Advantage Chemiluminescence Intact Parathyroid Hormone, Model 62-7022CEW · Traditional | 06/08/2004SE |
| K033727 | Nichols Advantage Bio-Intact PTH (1-84) ImmunoassayCEW · Traditional | 04/22/2004SE |
| K032188 | Nichols Advantage Aldosterone AssayCJM · Traditional | 07/31/2003SE |
| K022356 | Nichols Advantage Chemiluminescence Helicobactor Pylori Igg Antibodies ImmunoassayLYR · Traditional | 10/25/2002SE |
| K022472 | Parathyroid Hormone Test System/Nichols Advantage Quick-Intraoperative Bio-Intact PTH…CEW · Traditional | 10/09/2002SE |
| K013992 | Nichols Advantage Chemiluminescence Bio-Intact Parathyroid Hormone (1-84) ImmunoassayCEW · Traditional | 12/13/2001SE |
| K012367 | Vitamin D Test System Nichols Advantage 25-HYDROXYVITAMIN DJIT · Traditional | 10/09/2001SE |
Questions and answers
When was Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040 cleared by the FDA?
Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040 (K033302) received a 510(k) decision of Substantially Equivalent on January 26, 2004, 104 days after the submission was received.
What is the product code of K033302?
The FDA product code is CEW – Radioimmunoassay, Parathyroid Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1545.