Tina-Quant D-Dimer Test System
FDA 510(k) K011143 · Roche Diagnostics Corp.
510(k) numberK011143
Submission
- Device name
- Tina-Quant D-Dimer Test System
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- April 13, 2001
- Decision date
- May 29, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GHH – Fibrin Split Products
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7320
- Specialty
- Hematology
Other 510(k)s with product code GHH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K112120 | Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetGHH · Traditional | Diazyme Laboratories | 01/24/2013SE |
| K072288 | Pathfast D-DimerGHH · Traditional | Mitsubishi Kagaku Iatron | 05/06/2009SE |
| K070453 | Olympus D-Dimer Reagent, Model OSR6X135, Olympus D-Dimer Calibrator, Model ODR3033…GHH · Traditional | Olympus Life & Material Science Europa GmbH (Irish | 06/11/2007SE |
| K062203 | Tina-Quant D-Dimer Test SystemGHH · Traditional | Roche Diagnostics Corp. | 03/14/2007SE |
| K042890 | Triage D-Dimer Test, Model 98100GHH · Traditional | Biosite Incorporated | 11/29/2004SE |
| K030740 | Modification to Tina-Quant D-Dimer Test SystemGHH · Special | Roche Diagnostics Corp. | 04/01/2003SE |
| K021877 | Mda D-DimerGHH · Traditional | bioMerieux, Inc. | 08/07/2002SE |
| K993276 | Simplify D-Dimer, Model DCGK1GHH · Traditional | Agen Biomedical , Ltd. | 12/14/1999SE |
| K972316 | Opus D-DimerGHH · Traditional | Behring Diagnostics, Inc. | 09/09/1997SE |
| K945642 | Agen Dimertest Gold EiaGHH · Traditional | Agen Biomedical , Ltd. | 10/25/1995SE |
More from Agen Biomedical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Tina-Quant D-Dimer Test System cleared by the FDA?
Tina-Quant D-Dimer Test System (K011143) received a 510(k) decision of Substantially Equivalent on May 29, 2001, 46 days after the submission was received.
What is the product code of K011143?
The FDA product code is GHH – Fibrin Split Products, a Class II (moderate risk) device regulated under 21 CFR 864.7320.