NAVIOS FLOW CYTOMETER SYSTEM— 510(k) K130373
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K130373 for NAVIOS FLOW CYTOMETER SYSTEM, Substantially Equivalent on 2013-09-18. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code OYE
- 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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- K141932 — AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
More clearances from Beckman Coulter, Inc.
view allAdverse events under product code OYE
product code OYE- Malfunction
- 828
- Total
- 828
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.