STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER— 510(k) K000611
Substantially EquivalentBd Biosciences
FDA 510(k) clearance K000611 for STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER, Substantially Equivalent on 2000-05-18. 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
- Traditional
- Location
- San Jose, CA, US
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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.