Nichols Advantage Chemiluminescence Adrenocorticotropic Hormone
FDA 510(k) K962601 · Nichols Institute Diagnostics
510(k) numberK962601
Submission
- Device name
- Nichols Advantage Chemiluminescence Adrenocorticotropic Hormone
- Applicant
- Nichols Institute Diagnostics
San Juan Capistrano, CA, US - Received
- July 2, 1996
- Decision date
- December 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CKG – Radioimmunoassay, Acth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1025
- Specialty
- Clinical Chemistry
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| K002638 | Future Diagnostics B.V. Stat-Acth KitCKG · Traditional | Future Diagnostics B.V. | 01/17/2001SE |
| K982608 | Sangui Biotech, Inc. Acth (Adrenocorticotropic Hormone) Elisa KitCKG · Traditional | Sangui Biotech, Inc. | 08/19/1998SE |
| K960491 | Micro Haematocrit CentrifugeCKG · Traditional | Hawksley & Sons , Ltd. | 10/18/1996SE |
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More from Incstar Corp.
| 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 |
| 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 Adrenocorticotropic Hormone cleared by the FDA?
Nichols Advantage Chemiluminescence Adrenocorticotropic Hormone (K962601) received a 510(k) decision of Substantially Equivalent on December 24, 1996, 175 days after the submission was received.
What is the product code of K962601?
The FDA product code is CKG – Radioimmunoassay, Acth, a Class II (moderate risk) device regulated under 21 CFR 862.1025.