ARK Levetiracetam II Assay
Summary
Ark Diagnostics, Inc. received 510(k) clearance for ARK Levetiracetam II Assay, a ORI device. Cleared on 2024-02-27.
Details
Source
510(k) Clearance
External ID
K232522
Action Date
2024-02-27
Status
Traditional
Category
device
Product Code
ORI
Product Description
ARK Levetiracetam II Assay. Product code: ORI.
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. Ark Diagnostics, Inc. has received 4 total clearances in our database.
Ark Diagnostics, Inc. has 4 FDA actions in our database, including 4 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 Ark Diagnostics, Inc. have FDA actions?
Ark Diagnostics, Inc. has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232522" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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