BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010— 510(k) K081213
Substantially EquivalentBd Biosciences
FDA 510(k) clearance K081213 for BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010, Substantially Equivalent on 2008-08-14. Applicant: Bd Biosciences.
Clearance details
- Applicant
- Bd Biosciences
- Product code
- Code GKZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
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.