Brahms Diagnostica Dynotest Tg-Plus
FDA 510(k) K021057 · Brahms Diagnostica, LLC
510(k) numberK021057
Submission
- Device name
- Brahms Diagnostica Dynotest Tg-Plus
- Applicant
- Brahms Diagnostica, LLC
Norcross, GA, US - Received
- April 1, 2002
- Decision date
- September 17, 2002
- 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 |
| 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 |
| K994140 | Nichols Chemiluminescence Thyroglobulin, Model 60-4240MSW · Traditional | Nichols Institute Diagnostics | 05/09/2000SE |
| K991720 | Kronus Optiquant Thyroglobulin KitMSW · Traditional | Unchanged | 08/09/1999SE |
More from Unchanged
| 510(k) | Device | Decision |
|---|---|---|
| K033454 | Brahms Diagnostica Lumitest Trak HumanJZO · Traditional | 03/22/2004SE |
| K000287 | Brahms Diagnostica Lumitest Anti-TpoJZO · Traditional | 03/17/2000SE |
| K000286 | Brahms Diagnostica Lumitest Anti-TgJZO · Traditional | 03/17/2000SE |
| K992791 | Brahms Diagnostica Dynotest Anti-TpoJZO · Traditional | 11/12/1999SE |
| K992790 | Brahms Diagnostica Dynotest Anti-TgJZO · Traditional | 11/12/1999SE |
Questions and answers
When was Brahms Diagnostica Dynotest Tg-Plus cleared by the FDA?
Brahms Diagnostica Dynotest Tg-Plus (K021057) received a 510(k) decision of Substantially Equivalent on September 17, 2002, 169 days after the submission was received.
What is the product code of K021057?
The FDA product code is MSW – System, Test, Thyroglobulin, a Class II (moderate risk) device regulated under 21 CFR 866.6010.