TETRACHROME REAGENTS AND TETRACXP SYSTEM— 510(k) K121445
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K121445 for TETRACHROME REAGENTS AND TETRACXP SYSTEM, Substantially Equivalent on 2013-07-26. 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
- Special
- Location
- Miami, FL, US
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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.