INNOVANCE Antithrombin
FDA 510(k) K242952 · Siemens Healthcare Diagnostic Products GmbH
510(k) numberK242952
Submission
- Device name
- INNOVANCE Antithrombin
- Applicant
- Siemens Healthcare Diagnostic Products GmbH
Marburg, DE - Received
- September 25, 2024
- Decision date
- March 28, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JBQ – Antithrombin Iii Quantitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7060
- Specialty
- Hematology
Other 510(k)s with product code JBQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081769 | Innovance Antithrombin with Models OPFH03, OPFHO5JBQ · Traditional | Siemens Healthcare Diagnostics | 05/28/2009SE |
| K070301 | Hemosil AntithrombinJBQ · Special | Instrumentation Laboratory CO | 02/23/2007SE |
| K062431 | Hemosil Liquid AntithrombinJBQ · Special | Instrumentation Laboratory CO | 09/01/2006SE |
| K043007 | Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105JBQ · Traditional | Hyphen Biomed | 11/07/2005SE |
| K033775 | Hemosil Liquid Antithrombin XLJBQ · Special | Instrumentation Laboratory CO | 01/02/2004SE |
| K023991 | Chromocheck Antithrombin 25; Chromocheck Antithrombin 50JBQ · Traditional | Precision Biologic | 04/28/2003SE |
| K022550 | Coamatic LR Antithrombin, Note: Lr=Liquid ReagentsJBQ · Traditional | Instrumentation Laboratory CO | 08/27/2002SE |
| K022195 | Coamatic AT-400JBQ · Traditional | Instrumentation Laboratory CO | 08/07/2002SE |
| K994238 | Il Test Liquid AntithrombinJBQ · Traditional | Instrumentation Laboratory CO | 06/23/2000SE |
| K000361 | K-Assay At-IiiJBQ · Traditional | Kamiya Biomedical Co. | 04/26/2000SE |
More from Kamiya Biomedical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K253985 | INNOVANCE® D-Dimer 2.0 (SMN 10873803)DAP · Traditional | 08/11/2026SE |
| K232624 | CardioPhase® hsCRPDCN · Traditional | 11/27/2023SE |
| K172286 | Automated Blood Coagulation Analyzer CS-2500JPA · Traditional | 12/18/2017SE |
| K150678 | Sysmex Automated Blood Coagulation Analyzer CS-5100JPA · Traditional | 01/11/2016SE |
Questions and answers
When was INNOVANCE Antithrombin cleared by the FDA?
INNOVANCE Antithrombin (K242952) received a 510(k) decision of Substantially Equivalent on March 28, 2025, 184 days after the submission was received.
What is the product code of K242952?
The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.