Coulter Multi Q Prep
FDA 510(k) K935953 · Coulter Corp.
510(k) numberK935953
Submission
- Device name
- Coulter Multi Q Prep
- Applicant
- Coulter Corp.
Miami, FL, US - Received
- December 13, 1993
- Decision date
- March 11, 1994
- 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 |
| K022512 | Cellprep Sample Preparation System, Model 9518GKH · Traditional | Immunicon Corp. | 09/30/2002SE |
| K021150 | Coulter CellprepGKH · Traditional | Beckman Coulter, Inc. | 06/11/2002SE |
| 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 |
|---|---|---|
| K993356 | Coulter Hematology Analyzers with Irf & MRV AnalysesGKZ · Traditional | 04/20/2000SE |
| K991070 | Coulter Z2 AnalyzerGKL · Traditional | 05/11/1999SE |
| K990327 | Reticone System for Epics XL Flow Cytometry SystemsGKZ · Traditional | 04/26/1999SE |
| K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…GKZ · Traditional | 04/13/1999SE |
| K990352 | Coulter Ac T Diff 2 AnalyzerGKZ · Traditional | 04/01/1999SE |
| K984216 | Immuno-Trol Control CellsJPK · Traditional | 03/16/1999SE |
| K982167 | Cyto-Stat Trichrome CD45-FITC/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent with…GKZ · Traditional | 11/09/1998SE |
| K982166 | Cyto-Stat Trichrome CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent with…GKZ · Traditional | 11/05/1998SE |
| K982172 | Cyto-Stat CD3-FITC/CD56-RDI Monoclonal Antibody Reagent with Cyto-Stat/Coulter Clone…GKZ · Traditional | 09/24/1998SE |
| K973634 | Coulter Ac.T Diff AnalyzerGKZ · Traditional | 10/29/1997SE |
Questions and answers
When was Coulter Multi Q Prep cleared by the FDA?
Coulter Multi Q Prep (K935953) received a 510(k) decision of Substantially Equivalent on March 11, 1994, 88 days after the submission was received.
What is the product code of K935953?
The FDA product code is GKH – Apparatus, Automated Blood Cell Diluting, a Class I (low risk) device regulated under 21 CFR 864.5240.