Modified D-Di-Test Kit
FDA 510(k) K890399 · American Bioproducts Co.
510(k) numberK890399
Submission
- Device name
- Modified D-Di-Test Kit
- Applicant
- American Bioproducts Co.
Parsippany, NJ, US - Received
- January 24, 1989
- Decision date
- February 7, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K011143 | Tina-Quant D-Dimer Test SystemGHH · Special | Roche Diagnostics Corp. | 05/29/2001SE |
| K993276 | Simplify D-Dimer, Model DCGK1GHH · Traditional | Agen Biomedical , Ltd. | 12/14/1999SE |
| K972316 | Opus D-DimerGHH · Traditional | Behring Diagnostics, Inc. | 09/09/1997SE |
More from Behring Diagnostics, Inc.
| 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 |
| K964718 | Sta D-Di Calibrator KitDAP · Traditional | 05/23/1997SE |
| 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 |
Questions and answers
When was Modified D-Di-Test Kit cleared by the FDA?
Modified D-Di-Test Kit (K890399) received a 510(k) decision of Substantially Equivalent on February 7, 1989, 14 days after the submission was received.
What is the product code of K890399?
The FDA product code is GHH – Fibrin Split Products, a Class II (moderate risk) device regulated under 21 CFR 864.7320.