Sta D-Di Calibrator Kit
FDA 510(k) K964718 · American Bioproducts Co.
510(k) numberK964718
Submission
- Device name
- Sta D-Di Calibrator Kit
- Applicant
- American Bioproducts Co.
Parisppany, NJ, US - Received
- November 25, 1996
- Decision date
- May 23, 1997
- 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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| 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 |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K983460 | Star Automated Multi-Parametric AnalyzerJPA · Traditional | 11/12/1998SE |
| K971519 | Asserachrom Tpa Test KitGGP · Traditional | 08/19/1997SE |
| K964728 | Sta-Liatest D-Di Test KitDAP · Traditional | 06/26/1997SE |
| K964716 | Sta Liatest Control [N]+[P] KitGGN · Traditional | 06/26/1997SE |
| K962675 | Sta - Liatest VWF Test KitGJT · Traditional | 10/25/1996SE |
| K962671 | Sta-Vwf Calibrator KitGJT · Traditional | 09/13/1996SE |
| K962674 | Sta - VWF Control [N]+[P] KitGGN · Traditional | 07/23/1996SE |
| K961579 | Sta Compact Automated Multi-Parametric AnalyzerGKP · Traditional | 07/10/1996SE |
| K955040 | At-Iii Control Plasma KitGGC · Traditional | 01/31/1996SE |
| K954040 | Asserachrom Total Protein S KitGGP · Traditional | 11/13/1995SE |
Questions and answers
When was Sta D-Di Calibrator Kit cleared by the FDA?
Sta D-Di Calibrator Kit (K964718) received a 510(k) decision of Substantially Equivalent on May 23, 1997, 179 days after the submission was received.
What is the product code of K964718?
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.