Caltag Cal-Lyse
FDA 510(k) K965232 · Caltag Laboratories, Inc.
510(k) numberK965232
Submission
- Device name
- Caltag Cal-Lyse
- Applicant
- Caltag Laboratories, Inc.
Dowingtown, PA, US - Received
- December 31, 1996
- Decision date
- May 14, 1997
- 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
| 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 |
|---|---|---|
| K990641 | Caltag Fetal Hemoglobin TestGHQ · Traditional | 09/17/1999SE |
| K964856 | CD3 FITC/CD19 R-PE/CD45 Tri-Color Monoclonal Antibody CombinationGKZ · Traditional | 01/17/1997SE |
| K963954 | CD 19 R-Pe, CD19 Tri-Color Monoclonal AntibodyGKZ · Traditional | 11/25/1996SE |
| K951073 | CD3 TRI-COLOR/CD4 R-PE/CD8 Fitc Monoclonal Antibody CombinationGKZ · Traditional | 12/21/1995SE |
| K950918 | CD3 FITC/CD4 R-Pe Monoclonal Antibody CombinationGKZ · Traditional | 12/21/1995SE |
| K950917 | CD3 FITC/CD8 R-PE/CD45 Tri-Color Monoclonal Antibody CombinationGKZ · Traditional | 12/21/1995SE |
| K950916 | CD3 FITC/CD8 R-Pe Monoclonal Antibody CombinationGKZ · Traditional | 12/21/1995SE |
| K950919 | CD3 FITC/CD4 R-PE/CD45 Tri-Color Monoclonal Antibody CombinationGKZ · Traditional | 12/20/1995SE |
| K944128 | Caltag CD4 R-Pe Monoclonal AntibodyGKZ · Traditional | 06/20/1995SE |
| K944127 | Caltag CD3 Fitc, R-Pe, Tri-Color Monoclonal AntibodyGKZ · Traditional | 06/20/1995SE |
Questions and answers
When was Caltag Cal-Lyse cleared by the FDA?
Caltag Cal-Lyse (K965232) received a 510(k) decision of Substantially Equivalent on May 14, 1997, 134 days after the submission was received.
What is the product code of K965232?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.