Cyto-Stat/Coulter Clone T4-RD1/T8-FITC Mono Anti
FDA 510(k) K895917 · Coulter Immunology
510(k) numberK895917
Submission
- Device name
- Cyto-Stat/Coulter Clone T4-RD1/T8-FITC Mono Anti
- Applicant
- Coulter Immunology
Hialeah, FL, US - Received
- October 10, 1989
- Decision date
- December 29, 1989
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K922745 | Cyto-Stat/Coulter Clone CD3(IGG1)-FITC/T4-RD1GKZ · Traditional | 02/05/1993SE |
| K922744 | Cyto-Stat/Coulter Clone CD 3(IGG1)-FITC/T8-RD1GKZ · Traditional | 02/05/1993SE |
| K910473 | Cyto-Stat(R)/Coulter Clone(R) T11-RD1/B4-FITCGKZ · Traditional | 10/31/1991SE |
| K911793 | CoultercloneGKZ · Traditional | 07/09/1991SE |
| K893853 | Coulter Clone T8 Monoclonal AntibodyGKZ · Traditional | 03/02/1990SE |
| K893852 | Coulter Clone T4 Monoclonal AntibodyGKZ · Traditional | 03/02/1990SE |
| K894179 | Coulter Clone(R) MY4 Monoclonal AntibodyGKZ · Traditional | 02/12/1990SE |
| K884605 | Coulter Clone MO2GKZ · Traditional | 08/15/1989SE |
| K893419 | Coulter Clone Gam-Fitc Poly Anti (Igg & Igm)DEW · Traditional | 08/03/1989SE |
| K884020 | Coulter Clone B4 Monoclonal AntibodyGKZ · Traditional | 02/03/1989SE |
Questions and answers
When was Cyto-Stat/Coulter Clone T4-RD1/T8-FITC Mono Anti cleared by the FDA?
Cyto-Stat/Coulter Clone T4-RD1/T8-FITC Mono Anti (K895917) received a 510(k) decision of Substantially Equivalent on December 29, 1989, 80 days after the submission was received.
What is the product code of K895917?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.