Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-Hcg) Assay
FDA 510(k) K042676 · Nichols Institute Diagnostics
510(k) numberK042676
Submission
- Device name
- Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-Hcg) Assay
- Applicant
- Nichols Institute Diagnostics
San Clemente, CA, US - Received
- September 29, 2004
- Decision date
- December 17, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DHA – System, Test, Human Chorionic Gonadotropin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
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| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…DHA · Traditional | Abbott Laboratories | 05/19/2023SE |
| K221990 | Access Total ßhCG (5th IS)DHA · Traditional | Beckman Coulter, Inc. | 12/27/2022SE |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800…DHA · Traditional | Diazyme Laboratories, Inc. | 12/13/2021SE |
| K203227 | Elecsys HCG STATDHA · Traditional | Roche Diagnostics | 08/18/2021SE |
| K200210 | ADVIA Centaur® Total hCG assayDHA · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2021SE |
| K192547 | MAGLUMI 2000 HCG/ß-HCGDHA · Traditional | Shenzhen New Industries Biomedical Engineering… | 01/17/2020SE |
| K192790 | Atellica IM Total hCG (ThCG)DHA · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/30/2019SE |
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| K050784 | Nichols Advantage Aldosterone AssayCJM · Traditional | 06/01/2005SE |
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| 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 |
| K012367 | Vitamin D Test System Nichols Advantage 25-HYDROXYVITAMIN DJIT · Traditional | 10/09/2001SE |
Questions and answers
When was Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-Hcg) Assay cleared by the FDA?
Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-Hcg) Assay (K042676) received a 510(k) decision of Substantially Equivalent on December 17, 2004, 79 days after the submission was received.
What is the product code of K042676?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.