Dimertest(R) Latex
FDA 510(k) K882944 · Agen Biomedical , Ltd.
510(k) numberK882944
Submission
- Device name
- Dimertest(R) Latex
- Applicant
- Agen Biomedical , Ltd.
Brisbane, AU - Received
- July 14, 1988
- Decision date
- August 17, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
|---|---|---|
| K993276 | Simplify D-Dimer, Model DCGK1GHH · Traditional | 12/14/1999SE |
| K974596 | Dimertest Latex AssayDAP · Traditional | 05/26/1998SE |
| K945642 | Agen Dimertest Gold EiaGHH · Traditional | 10/25/1995SE |
| K905643 | Bed Red D-Dimer Whole Blood Agglutination AssayGHH · Traditional | 04/12/1991SE |
| K890189 | Agen Dimertest EiaDAP · Traditional | 03/03/1989SE |
Questions and answers
When was Dimertest(R) Latex cleared by the FDA?
Dimertest(R) Latex (K882944) received a 510(k) decision of Substantially Equivalent on August 17, 1988, 34 days after the submission was received.
What is the product code of K882944?
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.