X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
Summary
Scopio Labs , Ltd. received 510(k) clearance for X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application, a JOY device. Cleared on 2022-05-03.
Details
Source
510(k) Clearance
External ID
K220013
Action Date
2022-05-03
Status
Traditional
Category
device
Product Code
JOY
Product Description
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application. Product code: JOY.
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. Scopio Labs , Ltd. has received 2 total clearances in our database.
Scopio Labs , Ltd. has 2 FDA actions in our database, including 2 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 Scopio Labs , Ltd. have FDA actions?
Scopio Labs , Ltd. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K220013" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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