Biovation K-Manager
FDA 510(k) K925528 · Biovation, Inc.
510(k) numberK925528
Submission
- Device name
- Biovation K-Manager
- Applicant
- Biovation, Inc.
Hercules, CA, US - Received
- November 2, 1992
- Decision date
- February 5, 1993
- 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
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 |
|---|---|---|
| K923844 | Lyris 100/120 Laboratory Information SystemJJQ · Traditional | 12/11/1992SE |
| K915071 | Differential Counting BoardGKZ · Traditional | 01/17/1992SE |
| K853026 | Biovation Max Data Management SystemJQP · Traditional | 08/02/1985SE |
| K842401 | Chemistry ConsoleJQP · Traditional | 09/04/1984SE |
| K831830 | Lyris Modular Info SystemJQP · Traditional | 06/25/1984SE |
| K821534 | Hematology Data Management SysJGP · Traditional | 06/10/1982SE |
| K812604 | Biovation Urinalysis ReporterJQP · Traditional | 10/02/1981SE |
| K792045 | Biovation NephelometerJQX · Traditional | 10/30/1979SE |
| K790862 | Biovation Digital UrinometerJRE · Traditional | 06/28/1979SE |
| K781644 | Antibiotic NephelometerJQX · Traditional | 10/03/1978SE |
Questions and answers
When was Biovation K-Manager cleared by the FDA?
Biovation K-Manager (K925528) received a 510(k) decision of Substantially Equivalent on February 5, 1993, 95 days after the submission was received.
What is the product code of K925528?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.