BD Facscount CD4 Reagents with Model 339010
FDA 510(k) K081213 · Bd Biosciences
510(k) numberK081213
Submission
- Device name
- BD Facscount CD4 Reagents with Model 339010
- Applicant
- Bd Biosciences
San Jose, CA, US - Received
- April 30, 2008
- Decision date
- August 14, 2008
- 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 |
|---|---|---|
| K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow…OYE · Traditional | 02/27/2015SE |
| K090967 | BD Multitest 6-COLOR TBNK Reagent, Model 644611GKZ · Traditional | 07/31/2009SE |
| K071143 | BD Tritest CD3/CD4/CD45, Model 340383GKZ · Special | 06/06/2007SE |
| K071141 | BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402GKZ · Special | 06/06/2007SE |
| K062087 | BD Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962GKZ · Special | 09/14/2006SE |
| K060375 | BD Multitest 6-COLOR TBNK Reagent with BD Trucount Tubes with Models 337 and 166GKZ · Traditional | 06/06/2006SE |
| K041074 | BD Facscanto with BD Facsanto SoftwareGKZ · Traditional | 09/17/2004SE |
| K000611 | Steller CD61 Assay for Use on the Imagn 2000 Microvolume FluorimeterGKZ · Traditional | 05/18/2000SE |
| K000897 | Calibrite PERCP-CY5.5 Beads and Facscomp SoftwareGKZ · Traditional | 05/05/2000SE |
Questions and answers
When was BD Facscount CD4 Reagents with Model 339010 cleared by the FDA?
BD Facscount CD4 Reagents with Model 339010 (K081213) received a 510(k) decision of Substantially Equivalent on August 14, 2008, 106 days after the submission was received.
What is the product code of K081213?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.