Bed Red D-Dimer Whole Blood Agglutination Assay
FDA 510(k) K905643 · Agen Biomedical , Ltd.
510(k) numberK905643
Submission
- Device name
- Bed Red D-Dimer Whole Blood Agglutination Assay
- Applicant
- Agen Biomedical , Ltd.
Brisbane, AU - Received
- December 17, 1990
- Decision date
- April 12, 1991
- 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 |
|---|---|---|
| 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 |
| K890189 | Agen Dimertest EiaDAP · Traditional | 03/03/1989SE |
| K882944 | Dimertest(R) LatexDAP · Traditional | 08/17/1988SE |
Questions and answers
When was Bed Red D-Dimer Whole Blood Agglutination Assay cleared by the FDA?
Bed Red D-Dimer Whole Blood Agglutination Assay (K905643) received a 510(k) decision of Substantially Equivalent on April 12, 1991, 116 days after the submission was received.
What is the product code of K905643?
The FDA product code is GHH – Fibrin Split Products, a Class II (moderate risk) device regulated under 21 CFR 864.7320.