TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
Summary
Haemonetics Corporation received 510(k) clearance for TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge, a JPA device. Cleared on 2025-01-15.
Details
Source
510(k) Clearance
External ID
K243858
Action Date
2025-01-15
Status
Special
Category
device
Product Code
JPA
Product Description
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge. Product code: JPA.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Haemonetics Corporation has received 3 total clearances in our database.
Haemonetics Corporation has 5 FDA actions in our database, including 2 recalls and 3 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Haemonetics Corporation have FDA actions?
Haemonetics Corporation has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K243858" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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