TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge— 510(k) K183160
Substantially EquivalentHaemonetics Corporation
FDA 510(k) clearance K183160 for TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge, Substantially Equivalent on 2019-05-09. Applicant: Haemonetics Corporation. Device class: 2.
Clearance details
- Applicant
- Haemonetics Corporation
- Product code
- Code JPA
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Braintree, MA, US
Recent devices under product code JPA
view allMore clearances from Haemonetics Corporation
view allAdverse 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 →
Recalls naming K183160
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183160.
Data sourced from openFDA. This site is unofficial and independent of the FDA.