Hematrak Abnormal Recognition
FDA 510(k) K791041 · Geometric Data, Div. Smithkline Corp.
510(k) numberK791041
Submission
- Device name
- Hematrak Abnormal Recognition
- Applicant
- Geometric Data, Div. Smithkline Corp.
Mchenry, IL, US - Received
- June 5, 1979
- Decision date
- September 4, 1979
- 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 |
|---|---|---|
| K841852 | Autolyzer 800GKZ · Traditional | 09/05/1984SE |
| K811534 | HemaspinnerGKJ · Traditional | 08/18/1981SE |
| K791108 | Context FilterGKZ · Traditional | 07/17/1979SE |
| K790816 | Hematrak Model 480GKZ · Traditional | 07/17/1979SE |
| K790042 | Stain, Hemastain ReticGJH · Traditional | 02/15/1979SE |
| K780577 | Platelets/Cu MMGKZ · Traditional | 05/19/1978SE |
| K772139 | Re-Cell Slide RecapJOY · Traditional | 01/05/1978SE |
| K761207 | Hematrak RBC MorphologyGKZ · Traditional | 10/18/1977SE |
| K770680 | HematrakGKZ · Traditional | 07/01/1977SE |
| K770550 | Atypia Profile MonitorGKZ · Traditional | 06/17/1977SE |
Questions and answers
When was Hematrak Abnormal Recognition cleared by the FDA?
Hematrak Abnormal Recognition (K791041) received a 510(k) decision of Substantially Equivalent on September 4, 1979, 91 days after the submission was received.
What is the product code of K791041?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.