ONLINE TDM Phenytoin - Free Phenytoin application
Summary
Roche Diagnostics received 510(k) clearance for ONLINE TDM Phenytoin - Free Phenytoin application, a MOJ device. Cleared on 2023-03-30.
Details
Source
510(k) Clearance
External ID
K230161
Action Date
2023-03-30
Status
Traditional
Category
device
Product Code
MOJ
Product Description
ONLINE TDM Phenytoin - Free Phenytoin application. Product code: MOJ.
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. Roche Diagnostics has received 34 total clearances in our database.
Roche Diagnostics has 34 FDA actions in our database, including 34 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 Roche Diagnostics have FDA actions?
Roche Diagnostics has 34 FDA actions in our database, including 0 recalls and 34 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K230161" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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