CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
Summary
Sebia received 510(k) clearance for CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument, a GKA device. Cleared on 2024-04-04.
Details
Source
510(k) Clearance
External ID
K232027
Action Date
2024-04-04
Status
Traditional
Category
device
Product Code
GKA
Product Description
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument. Product code: GKA.
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. Sebia has received 4 total clearances in our database.
Sebia 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 Sebia have FDA actions?
Sebia 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 "K232027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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