Brahms Diagnostica Dynotest Anti-Tpo
FDA 510(k) K992791 · Brahms Diagnostica, LLC
510(k) numberK992791
Submission
- Device name
- Brahms Diagnostica Dynotest Anti-Tpo
- Applicant
- Brahms Diagnostica, LLC
Norcross, GA, US - Received
- August 19, 1999
- Decision date
- November 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JZO – System, Test, Thyroid Autoantibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5870
- Specialty
- Immunology
Other 510(k)s with product code JZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase IIJZO · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/17/2025SE |
| K240469 | Access TPO AntibodyJZO · Traditional | Beckman Coulter, Inc. | 08/09/2024SE |
| K213517 | Access Thyroglobulin Antibody IIJZO · Traditional | Beckman Coulter, Inc. | 09/26/2023SE |
| K222610 | Elecsys Anti-TgJZO · Traditional | Roche Diagnostics | 09/15/2023SE |
| K193313 | Elecsys Anti-TSHRJZO · Traditional | Roche Diagnostics | 02/27/2020SE |
| K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…JZO · Traditional | Phadia AB | 03/25/2016SE |
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialJZO · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/03/2016SE |
| K092229 | Thyretain TM Tsi Reporter BioassayJZO · Traditional | Diagnostic Hybrids, Inc. | 05/18/2010SE |
| K090760 | Theratest El-Anti-Tpo and Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120JZO · Traditional | Theratest Laboratories, Inc. | 09/03/2009SE |
| K083391 | Thyroid Stimulating Immunoglobulin Reporter AssayJZO · Traditional | Diagnostic Hybrids, Inc. | 05/21/2009SE |
More from Diagnostic Hybrids, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033454 | Brahms Diagnostica Lumitest Trak HumanJZO · Traditional | 03/22/2004SE |
| K021057 | Brahms Diagnostica Dynotest Tg-PlusMSW · Traditional | 09/17/2002SE |
| K000287 | Brahms Diagnostica Lumitest Anti-TpoJZO · Traditional | 03/17/2000SE |
| K000286 | Brahms Diagnostica Lumitest Anti-TgJZO · Traditional | 03/17/2000SE |
| K992790 | Brahms Diagnostica Dynotest Anti-TgJZO · Traditional | 11/12/1999SE |
Questions and answers
When was Brahms Diagnostica Dynotest Anti-Tpo cleared by the FDA?
Brahms Diagnostica Dynotest Anti-Tpo (K992791) received a 510(k) decision of Substantially Equivalent on November 12, 1999, 85 days after the submission was received.
What is the product code of K992791?
The FDA product code is JZO – System, Test, Thyroid Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.