Opticlone(Tm CD3 FITC/CD19 Pe Monoclonal Antibodies
FDA 510(k) K946335 · Immunotech, Inc.
510(k) numberK946335
Submission
- Device name
- Opticlone(Tm CD3 FITC/CD19 Pe Monoclonal Antibodies
- Applicant
- Immunotech, Inc.
Westbrook, ME, US - Received
- December 29, 1994
- Decision date
- October 20, 1995
- 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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| 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 |
|---|---|---|
| K954188 | Opticlone IGG1 FITC/IGG2A Pe Isotypic ControlGKZ · Traditional | 11/03/1995SE |
| K953498 | Opticlone IGG1 FITC/IGG1 Pe Isotypic ControlGKZ · Traditional | 09/08/1995SE |
| K952789 | Opticlone CD4FITC/CD8 Pe Monoclonal AntibodiesGKZ · Traditional | 08/14/1995SE |
| K952182 | Opticlone CD3/CD8 Monoclonal AntibodiesGKZ · Traditional | 07/05/1995SE |
| K950626 | Opticlone CD3/CD4 Monoclonal AntibodiesGKZ · Traditional | 05/05/1995SE |
| K931228 | Progesterone Radioimmunoassay KitJLS · Traditional | 10/22/1993SE |
| K911634 | Microzyme(Tm) Free T4 Enzyme Immunoassay TestCEC · Traditional | 06/24/1991SE |
| K911153 | Microzyme Phencyclidine Enzyme Immunoassay Test KTLCM · Traditional | 06/18/1991SE |
| K910411 | Microzyme TSH Enzyme Immunoassay KitJLW · Traditional | 04/03/1991SE |
| K905777 | Microzyme Thyroid Uptake Enzyme Immunoassay KitCEE · Traditional | 01/30/1991SE |
Questions and answers
When was Opticlone(Tm CD3 FITC/CD19 Pe Monoclonal Antibodies cleared by the FDA?
Opticlone(Tm CD3 FITC/CD19 Pe Monoclonal Antibodies (K946335) received a 510(k) decision of Substantially Equivalent on October 20, 1995, 295 days after the submission was received.
What is the product code of K946335?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.