Cytomics FC 500 Series (MPL or MCL) Flow Cytometer— 510(k) K182886
Substantially EquivalentBeckman Coulter
FDA 510(k) clearance K182886 for Cytomics FC 500 Series (MPL or MCL) Flow Cytometer, Substantially Equivalent on 2019-09-06. Applicant: Beckman Coulter. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter
- 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
- Miami, FL, 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.