TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge— 510(k) K251024
Substantially EquivalentHaemonetics
FDA 510(k) clearance K251024 for TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge, Substantially Equivalent on 2025-04-30. Applicant: Haemonetics. Device class: 2.
Clearance details
- Applicant
- Haemonetics
- Product code
- Product code JPA
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boston, MA, US
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Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
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.