Cellprep Sample Preparation System, Model 9518
FDA 510(k) K022512 · Immunicon Corp.
510(k) numberK022512
Submission
- Device name
- Cellprep Sample Preparation System, Model 9518
- Applicant
- Immunicon Corp.
Huntingdon Valley, PA, US - Received
- July 30, 2002
- Decision date
- September 30, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| 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 |
|---|---|---|
| K060110 | Celltracks Analyzer IINQI · Traditional | 03/16/2006SE |
| K050145 | Celltracka Analyzer IINQI · Traditional | 03/15/2005SE |
| K040077 | Immunicon Celltracks Autoprep SystemGKH · Traditional | 03/12/2004SE |
| K030263 | Immunicon Celltracks AnalyzerGKZ · Traditional | 11/24/2003SE |
| K030596 | Immunicon Cellsave Preservative TubeJKA · Traditional | 08/08/2003SE |
Questions and answers
When was Cellprep Sample Preparation System, Model 9518 cleared by the FDA?
Cellprep Sample Preparation System, Model 9518 (K022512) received a 510(k) decision of Substantially Equivalent on September 30, 2002, 62 days after the submission was received.
What is the product code of K022512?
The FDA product code is GKH – Apparatus, Automated Blood Cell Diluting, a Class I (low risk) device regulated under 21 CFR 864.5240.