Tritest Reagent CD3 FITC/CD16+CD56 PE/CD45 Percp;With Trucount Absolute Count Tubes
FDA 510(k) K971110 · Becton Dickinson Immunocytometry Systems
510(k) numberK971110
Submission
- Device name
- Tritest Reagent CD3 FITC/CD16+CD56 PE/CD45 Percp;With Trucount Absolute Count Tubes
- Applicant
- Becton Dickinson Immunocytometry Systems
San Jose, CA, US - Received
- March 26, 1997
- Decision date
- November 25, 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
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| 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
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| K040725 | BD Facscanto SystemGKZ · Traditional | 09/10/2004SE |
| K040026 | BD Facs 7-COLOR Setup BeadsGKZ · Traditional | 09/10/2004SE |
| K980858 | Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing SolutionGKZ · Traditional | 05/22/1998SE |
| K974360 | Multitest CD3/CD8/CD45/CD4GKZ · Traditional | 03/11/1998SE |
| K973483 | Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument SetGKZ · Traditional | 02/17/1998SE |
| K971205 | Tri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute Count TubesGKZ · Traditional | 12/01/1997SE |
| K970326 | Tritest Reagent CD3 FITC/CD8 PE/CD45 Percp;With Trucount Absolute Count TubesGKZ · Traditional | 11/21/1997SE |
| K965053 | Tritest Reagent CD3 FITC/CD4 PE/CD45 Percp; Trucount Absolute Count TubesGKZ · Traditional | 11/21/1997SE |
| K970742 | Tritest CD3 FITC/CD19 PE/CD45 Percp Reagent with Trucount Absolute Count TubesGKZ · Traditional | 10/22/1997SE |
| K970836 | Trucount Absolute Count Tubes/Counting Control BeadsGKZ · Traditional | 08/26/1997SE |
Questions and answers
When was Tritest Reagent CD3 FITC/CD16+CD56 PE/CD45 Percp;With Trucount Absolute Count Tubes cleared by the FDA?
Tritest Reagent CD3 FITC/CD16+CD56 PE/CD45 Percp;With Trucount Absolute Count Tubes (K971110) received a 510(k) decision of Substantially Equivalent on November 25, 1997, 244 days after the submission was received.
What is the product code of K971110?
The FDA product code is GKZ – Counter, Differential Cell, a Class II (moderate risk) device regulated under 21 CFR 864.5220.