Nichols Advantage Chemiluminescence Helicobactor Pylori Igg Antibodies Immunoassay
FDA 510(k) K022356 · Nichols Institute Diagnostics
510(k) numberK022356
Submission
- Device name
- Nichols Advantage Chemiluminescence Helicobactor Pylori Igg Antibodies Immunoassay
- Applicant
- Nichols Institute Diagnostics
San Clemente, CA, US - Received
- July 19, 2002
- Decision date
- October 25, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYR – Helicobacter Pylori
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3110
- Specialty
- Microbiology
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| K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetLYR · Traditional | DiaSorin, Inc. | 08/31/2018SE |
| K181400 | H. Pylori ChekLYR · Traditional | Techlab, Inc. | 08/21/2018SE |
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| K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetLYR · Traditional | DiaSorin, Inc. | 07/22/2016SE |
| K153661 | ImmunoCard STAT! HpSALYR · Traditional | Meridian Bioscience, Inc. | 03/14/2016SE |
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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 |
| 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 Chemiluminescence Helicobactor Pylori Igg Antibodies Immunoassay cleared by the FDA?
Nichols Advantage Chemiluminescence Helicobactor Pylori Igg Antibodies Immunoassay (K022356) received a 510(k) decision of Substantially Equivalent on October 25, 2002, 98 days after the submission was received.
What is the product code of K022356?
The FDA product code is LYR – Helicobacter Pylori, a Class I (low risk) device regulated under 21 CFR 866.3110.