STA® - Liatest® D-Di
FDA 510(k) K162227 · Diagnostica Stago
510(k) numberK162227
Submission
- Device name
- STA® - Liatest® D-Di
- Applicant
- Diagnostica Stago
Asnieres Sur Seine, FR - Received
- August 8, 2016
- Decision date
- December 10, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DAP – Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7320
- Specialty
- Hematology
Other 510(k)s with product code DAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253985 | INNOVANCE® D-Dimer 2.0 (SMN 10873803)DAP · Traditional | Siemens Healthcare Diagnostic Products GmbH | 08/11/2026SE |
| K172903 | HemosIL D-Dimer HS 500DAP · Special | Instrumentation Laboratory CO | 11/22/2017SE |
| K160885 | HemosIL D-Dimer HSDAP · Special | Instrumentation Laboratory CO | 10/27/2016SE |
| K151534 | HemosIL D-Dimer HSDAP · Special | Instrumentation Laboratory CO | 07/06/2015SE |
| K141144 | Sta Liatest D-DiDAP · Traditional | Diagnostica Stago | 09/03/2014SE |
| K112818 | Vidas D-Dimer Exclusion II (DEX2)DAP · Traditional | bioMerieux, Inc. | 07/31/2012SE |
| K110303 | Stratus CS Acute Care D-DimerDAP · Traditional | Siemens Healthcare Diagnostics | 05/16/2011SE |
| K093626 | Innovance D-Dimer, Model OPBP09DAP · Traditional | Siemens Healthcare Diagnostics | 11/29/2010SE |
| K090264 | Hemosil D-Dimer HS 500, ControlsDAP · Traditional | Instrumentation Laboratory CO | 02/05/2010SE |
| K091916 | Innovance D-Dimer, Model OPBP09DAP · Traditional | Siemens Healthcare Diagnostics | 10/29/2009SE |
More from Siemens Healthcare Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K253658 | STA Satellite Max®JPA · Traditional | 04/27/2026SE |
| K141144 | Sta Liatest D-DiDAP · Traditional | 09/03/2014SE |
| K120014 | Sta- Coag Control (N+Abn) PlusGGN · Traditional | 03/14/2013SE |
| K130090 | Sta Compact MaxJPA · Special | 02/12/2013SE |
| K111822 | Sta(R) - Liquid Anti-Xa, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWHKFF · Traditional | 10/26/2011SE |
| K092937 | Sta-Hybrid Hep CalibratorJIT · Traditional | 08/02/2010SE |
| K093167 | Sta Compact Automated Multi-Parametric AnalyzerJPA · Special | 12/22/2009SE |
| K092170 | Sta Liatest Free PSGGP · Special | 12/22/2009SE |
| K093001 | Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric AnalyzerJPA · Special | 12/18/2009SE |
| K092113 | Sta - Free PS CalibratorJIX · Traditional | 11/13/2009SE |
Questions and answers
When was STA® - Liatest® D-Di cleared by the FDA?
STA® - Liatest® D-Di (K162227) received a 510(k) decision of Substantially Equivalent on December 10, 2016, 124 days after the submission was received.
What is the product code of K162227?
The FDA product code is DAP – Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 864.7320.