Nichols Advantage Chemiluminescence Ferritin Immunoassay
FDA 510(k) K984186 · Nichols Institute Diagnostics
510(k) numberK984186
Submission
- Device name
- Nichols Advantage Chemiluminescence Ferritin Immunoassay
- Applicant
- Nichols Institute Diagnostics
San Juan Capistrano, CA, US - Received
- November 23, 1998
- Decision date
- February 2, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DBF – Ferritin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5340
- Specialty
- Immunology
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| 510(k) | Device | Decision |
|---|---|---|
| K050784 | Nichols Advantage Aldosterone AssayCJM · Traditional | 06/01/2005SE |
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| 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 |
| K033302 | Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040CEW · Special | 01/26/2004SE |
| 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 |
Questions and answers
When was Nichols Advantage Chemiluminescence Ferritin Immunoassay cleared by the FDA?
Nichols Advantage Chemiluminescence Ferritin Immunoassay (K984186) received a 510(k) decision of Substantially Equivalent on February 2, 1999, 71 days after the submission was received.
What is the product code of K984186?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.