Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry System
FDA 510(k) K935720 · Ortho Diagnostic Systems, Inc.
510(k) numberK935720
Submission
- Device name
- Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry System
- Applicant
- Ortho Diagnostic Systems, Inc.
Raritan, NJ, US - Received
- November 30, 1993
- Decision date
- May 9, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKZ – Counter, Differential Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
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| 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 |
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| K955638 | Synthafax Aptt ReagentGFO · Traditional | 04/23/1996SE |
Questions and answers
When was Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry System cleared by the FDA?
Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry System (K935720) received a 510(k) decision of Substantially Equivalent on May 9, 1996, 891 days after the submission was received.
What is the product code of K935720?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.