Advanced D-Dimer
FDA 510(k) K992957 · Dade Behring, Inc.
510(k) numberK992957
Submission
- Device name
- Advanced D-Dimer
- Applicant
- Dade Behring, Inc.
P.O. Box 6101, Newark, DE, US - Received
- September 2, 1999
- Decision date
- January 28, 2000
- 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
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| 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 |
| K162227 | STA® - Liatest® D-DiDAP · Traditional | Diagnostica Stago | 12/10/2016SE |
| 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 |
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Questions and answers
When was Advanced D-Dimer cleared by the FDA?
Advanced D-Dimer (K992957) received a 510(k) decision of Substantially Equivalent on January 28, 2000, 148 days after the submission was received.
What is the product code of K992957?
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.