System 9000 Diff Model Automated Cell Counter
FDA 510(k) K882612 · Baker Instructions Corp.
510(k) numberK882612
Submission
- Device name
- System 9000 Diff Model Automated Cell Counter
- Applicant
- Baker Instructions Corp.
Winchester, VA, US - Received
- June 24, 1988
- Decision date
- September 7, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKZ – Counter, Differential Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
Other 510(k)s with product code GKZ
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|---|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ · Traditional | Sysmex America, Inc. | 05/27/2026SE |
| K243348 | Athelas HomeGKZ · Traditional | Athelas, Inc. | 02/06/2026SE |
| K251249 | Tru Hematology TestGKZ · Traditional | Truvian Sciences, Inc. | 01/16/2026SE |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 06/25/2025SE |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 06/25/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | Abbott Laboratories | 02/20/2025SE |
| K240402 | Cito CBC SystemGKZ · Dual Track | Cytochip, Inc. | 02/03/2025SE |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…GKZ · Traditional | Beckman Coulter, Inc. | 07/05/2024SE |
| K232946 | Yumizen H2500GKZ · Traditional | Horiba Abx SAS | 05/21/2024SE |
| K240636 | HemoScreen Hematology AnalyzerGKZ · Abbreviated | Pixcell Medical Technologies | 05/02/2024SE |
More from Pixcell Medical Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K873596 | Baker TDM Theophylline AssayKLS · Traditional | 10/20/1987SE |
| K870603 | System 9000 Automated Cell CounterGKL · Traditional | 03/31/1987SE |
| K854173 | Ucd Urine Specimen CollectorKNX · Traditional | 11/04/1985SE |
| K850386 | System 8000 Cell CounterGKL · Traditional | 05/02/1985SE |
| K833116 | Spirit Chemistry SystemJJE · Traditional | 11/07/1983SE |
| K832716 | Encore Chemistry AnalyzerJJG · Traditional | 10/04/1983SE |
| K830641 | Encore Chemistry AnalyzerJJG · Traditional | 04/05/1983SE |
| K821956 | Haem-C Plus Blood Reference ControlsJCN · Traditional | 07/30/1982SE |
| K811694 | Centrifichem Alt/Agpt Optimized ReagentCKA · Traditional | 07/01/1981SE |
Questions and answers
When was System 9000 Diff Model Automated Cell Counter cleared by the FDA?
System 9000 Diff Model Automated Cell Counter (K882612) received a 510(k) decision of Substantially Equivalent on September 7, 1988, 75 days after the submission was received.
What is the product code of K882612?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.