Cell-Dyn 900 Hematology Analyzer
FDA 510(k) K832643 · Abbott Diagnostics
510(k) numberK832643
Submission
- Device name
- Cell-Dyn 900 Hematology Analyzer
- Applicant
- Abbott Diagnostics
Mountain View, CA, US - Received
- August 4, 1983
- Decision date
- September 26, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKL – Counter, Cell, Automated (Particle Counter)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5200
- Specialty
- Hematology
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| K050235 | Iq 200 Urine Analyzer Body Fluids ModuleGKL · Traditional | Iris International, Inc. | 03/23/2005SE |
| K032677 | Sysmex POCH-100IGKL · Traditional | Sysmex America, Inc. | 02/11/2004SE |
| K022331 | Advia 120 Hematology System, Cerebrospinal Fluid MethodGKL · Special | Bayer Diagnostics Corp. | 09/11/2002SE |
| K001683 | Sysmex R-500GKL · Traditional | Sysmex Corporation of America | 08/21/2000SE |
| K991070 | Coulter Z2 AnalyzerGKL · Traditional | Coulter Corp. | 05/11/1999SE |
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| 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 Cell-Dyn 900 Hematology Analyzer cleared by the FDA?
Cell-Dyn 900 Hematology Analyzer (K832643) received a 510(k) decision of Substantially Equivalent on September 26, 1983, 53 days after the submission was received.
What is the product code of K832643?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.