BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402— 510(k) K071141
Substantially EquivalentBd Biosciences
FDA 510(k) clearance K071141 for BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402, Substantially Equivalent on 2007-06-06. Applicant: Bd Biosciences. Device class: 2.
Clearance details
- Applicant
- Bd Biosciences
- Product code
- Code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
Recent devices under product code GKZ
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view all- K141468 — BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)
- K090967 — BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611
- K081213 — BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010
- K071143 — BD TRITEST CD3/CD4/CD45, MODEL 340383
- K062087 — BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962
Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.