Minutex D-Dimer Latex Test
FDA 510(k) K920668 · Biopool AB
510(k) numberK920668
Submission
- Device name
- Minutex D-Dimer Latex Test
- Applicant
- Biopool AB
Ontario, L7l 6b8, CA - Received
- February 13, 1992
- Decision date
- October 16, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
|---|---|---|
| K941752 | Spectrolyse Antiplasmin KitGGP · Traditional | 09/25/1995SESK |
| K942087 | Biopool VWF Eld Kit and VWF Eld Bulk PlatesGGP · Traditional | 07/13/1995SE |
| K934314 | Tintelizer(R) TpaGGP · Traditional | 02/23/1994SE |
| K923499 | Spectrolyse Heparin KitKFF · Traditional | 01/27/1994SE |
| K932463 | Bioclot laGIR · Traditional | 09/27/1993SE |
| K922782 | Spectrolyse/Pl Pai KitGGP · Traditional | 10/09/1992SE |
| K915163 | Protein S Eid Kit and Protein S Eid Bulk PlatesGGP · Traditional | 01/06/1992SE |
| K914307 | Spectrolyse Protein C KitGGP · Traditional | 12/09/1991SE |
| K912025 | Spectrolyse Plasminogen SK KitGGP · Traditional | 08/22/1991SE |
| K902566 | Biopool Protein C Eid Kit and Bulk PlatesGGP · Traditional | 08/09/1990SE |
Questions and answers
When was Minutex D-Dimer Latex Test cleared by the FDA?
Minutex D-Dimer Latex Test (K920668) received a 510(k) decision of Substantially Equivalent on October 16, 1992, 246 days after the submission was received.
What is the product code of K920668?
The FDA product code is GHH – Fibrin Split Products, a Class II (moderate risk) device regulated under 21 CFR 864.7320.