Nichols Chemiluminescence Thyroglobulin, Model 60-4240
FDA 510(k) K994140 · Nichols Institute Diagnostics
510(k) numberK994140
Submission
- Device name
- Nichols Chemiluminescence Thyroglobulin, Model 60-4240
- Applicant
- Nichols Institute Diagnostics
San Juan Capistrano, CA, US - Received
- December 8, 1999
- Decision date
- May 9, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSW – System, Test, Thyroglobulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
Other 510(k)s with product code MSW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242981 | Atellica IM Thyroglobulin (Tg)MSW · Traditional | Siemens Healthcare Diagnostics, Inc. | 06/20/2025SE |
| K240927 | Access ThyroglobulinMSW · Traditional | Beckman Coulter, Inc. | 06/28/2024SE |
| K241423 | Access ThyroglobulinMSW · Traditional | Beckman Coulter, Inc. | 06/07/2024SE |
| K221890 | Elecsys Tg IIMSW · Traditional | Roche Diagnostics | 09/30/2023SE |
| K220972 | Access ThyroglobulinMSW · Traditional | Beckman Coulter, Inc. | 09/15/2023SE |
| K031269 | Access Thyroglobulin Reagents on the Access Immunoassay SystemsMSW · Special | Beckman Coulter, Inc. | 05/02/2003SE |
| K021057 | Brahms Diagnostica Dynotest Tg-PlusMSW · Traditional | Brahms Diagnostica, LLC | 09/17/2002SE |
| K002888 | Nichols Advantage ThyroglobMSW · Traditional | Nichols Institute Diagnostics | 10/20/2000SE |
| K002905 | Access Thyroglobulin Reagents on the Access AnalyzerMSW · Traditional | Beckman Coulter, Inc. | 10/19/2000SE |
| K991720 | Kronus Optiquant Thyroglobulin KitMSW · Traditional | Unchanged | 08/09/1999SE |
More from Unchanged
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|---|---|---|
| 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 Chemiluminescence Thyroglobulin, Model 60-4240 cleared by the FDA?
Nichols Chemiluminescence Thyroglobulin, Model 60-4240 (K994140) received a 510(k) decision of Substantially Equivalent on May 9, 2000, 153 days after the submission was received.
What is the product code of K994140?
The FDA product code is MSW – System, Test, Thyroglobulin, a Class II (moderate risk) device regulated under 21 CFR 866.6010.