Sysmex DD-100 Whole Blood Dilution System
FDA 510(k) K882767 · Toa Medical Electronics USA, Inc.
510(k) numberK882767
Submission
- Device name
- Sysmex DD-100 Whole Blood Dilution System
- Applicant
- Toa Medical Electronics USA, Inc.
Los Alamitos, CA, US - Received
- July 6, 1988
- Decision date
- July 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKH – Apparatus, Automated Blood Cell Diluting
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.5240
- Specialty
- Hematology
Other 510(k)s with product code GKH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100684 | Celltracks Autoprep System MODEL:9541GKH · Traditional | Veridex, LLC | 08/26/2010SE |
| K040077 | Immunicon Celltracks Autoprep SystemGKH · Traditional | Immunicon Corp. | 03/12/2004SE |
| K022512 | Cellprep Sample Preparation System, Model 9518GKH · Traditional | Immunicon Corp. | 09/30/2002SE |
| K021150 | Coulter CellprepGKH · Traditional | Beckman Coulter, Inc. | 06/11/2002SE |
| K935953 | Coulter Multi Q PrepGKH · Traditional | Coulter Corp. | 03/11/1994SE |
| K923530 | Coulter Multi-Q-PrepGKH · Traditional | Coulter Electronics, Inc. | 10/14/1992SE |
| K904795 | Facsprep Robotic Sample Preparation SystemGKH · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/31/1990SE |
| K852373 | AD150, Automated Hematology DilutorGKH · Traditional | Abbott Diagnostics | 07/05/1985SE |
| K842747 | Hycel Dilutor, Various Models/MultiGKH · Traditional | R&D Systems, Inc. | 10/01/1984SE |
| K842446 | Dilu-Matic 140GKH · Traditional | Abbott Diagnostics | 09/06/1984SE |
More from Abbott Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K936023 | Sysmex SE-9000 Automated Hematology AnalyzerGKZ · Traditional | 05/02/1994SE |
| K933886 | Toa Medical Electronics CA-5000JPA · Traditional | 01/27/1994SE |
| K931149 | CA-1000 Automated Coagulation AnalyzerJPA · Traditional | 11/03/1993SE |
| K920544 | Sysmex Hematology System AccessoriesGKZ · Traditional | 04/29/1992SE |
| K914744 | Sysmex NE-1500, ModificationGKZ · Traditional | 12/30/1991SE |
| K912494 | Sysmex(Tm) R-3000 Automated Reticulocyte AnalyzerGKL · Traditional | 09/10/1991SE |
| K911173 | Sysmex F-310GKL · Traditional | 07/26/1991SE |
| K911172 | Sysmex F-610GKL · Traditional | 07/26/1991SE |
| K910849 | Sysmex F-810GKL · Traditional | 07/26/1991SE |
| K910745 | Hemoglobin ReagentGKR · Traditional | 07/11/1991SE |
Questions and answers
When was Sysmex DD-100 Whole Blood Dilution System cleared by the FDA?
Sysmex DD-100 Whole Blood Dilution System (K882767) received a 510(k) decision of Substantially Equivalent on July 18, 1988, 12 days after the submission was received.
What is the product code of K882767?
The FDA product code is GKH – Apparatus, Automated Blood Cell Diluting, a Class I (low risk) device regulated under 21 CFR 864.5240.