Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
Summary
Fujirebio Diagnostics,Inc. received 510(k) clearance for Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, a SET device. Cleared on 2025-05-16.
Details
Source
510(k) Clearance
External ID
K242706
Action Date
2025-05-16
Status
Traditional
Category
device
Product Code
SET
Product Description
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. Product code: SET.
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 389 device clearances issued this month. Fujirebio Diagnostics,Inc. has received 3 total clearances in our database.
Fujirebio Diagnostics,Inc. has 10 FDA actions in our database, including 7 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 Fujirebio Diagnostics,Inc. have FDA actions?
Fujirebio Diagnostics,Inc. has 10 FDA actions in our database, including 7 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K242706" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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