AD150, Automated Hematology Dilutor
FDA 510(k) K852373 · Abbott Diagnostics
510(k) numberK852373
Submission
- Device name
- AD150, Automated Hematology Dilutor
- Applicant
- Abbott Diagnostics
Mountain View, CA, US - Received
- June 4, 1985
- Decision date
- July 5, 1985
- 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 |
| K882767 | Sysmex DD-100 Whole Blood Dilution SystemGKH · Traditional | Toa Medical Electronics USA, Inc. | 07/18/1988SE |
| 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 |
|---|---|---|
| K964185 | Imx Ca 125LTK · Traditional | 11/04/1997SE |
| K972182 | Abbott Strep a ControlsMJZ · Traditional | 08/13/1997SE |
| K961439 | Abbott Cell-Dyn 4000 SystemGKZ · Traditional | 10/18/1996SE |
| K890491 | Cell-Dyn 3000 Multi-Parameter Hematology AnalyerGKZ · Traditional | 04/18/1989SE |
| K881242 | Cell-Dyn Rapid-Lyse and HemogloblinGJZ · Traditional | 04/21/1988SE |
| K881130 | Cell-Dyn Isotonic DiluentGIF · Traditional | 03/31/1988SE |
| K873348 | Cell-Dyn Diff Screen, Auto. & Semi Auto. Lytic Ag.GGK · Traditional | 09/09/1987SE |
| K873347 | Cell-Dyn Diff. Screen Isotonic DiluentGIF · Traditional | 09/09/1987SE |
| K873408 | Model 690 SpectrophotometerJJQ · Traditional | 09/08/1987SE |
| K872761 | Cell-Dyn 610 Hematology AnalyzerGKZ · Traditional | 08/06/1987SE |
Questions and answers
When was AD150, Automated Hematology Dilutor cleared by the FDA?
AD150, Automated Hematology Dilutor (K852373) received a 510(k) decision of Substantially Equivalent on July 5, 1985, 31 days after the submission was received.
What is the product code of K852373?
The FDA product code is GKH – Apparatus, Automated Blood Cell Diluting, a Class I (low risk) device regulated under 21 CFR 864.5240.