SECQUIRE CELL SEPARATOR— 510(k) K024080
Substantially EquivalentPerfusion Partners & Assoc., Inc.
FDA 510(k) clearance K024080 for SECQUIRE CELL SEPARATOR, Substantially Equivalent on 2003-07-02. Applicant: Perfusion Partners & Assoc., Inc.. Device class: 1.
Clearance details
- Applicant
- Perfusion Partners & Assoc., Inc.
- Product code
- Code JQC
- Device class
- Class 1
- Regulation
- 21 CFR 862.2050
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crofton, MD, US
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Adverse events under product code JQC
product code JQC- Other
- 1
- Total
- 1
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.