The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug
Summary
Thermo Fisher Scientific received 510(k) clearance for The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL, a JWY device. Cleared on 2024-12-19.
Details
Source
510(k) Clearance
External ID
K243169
Action Date
2024-12-19
Status
Traditional
Category
device
Product Code
JWY
Product Description
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. Product code: JWY.
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. Thermo Fisher Scientific has received 23 total clearances in our database.
Thermo Fisher Scientific has 23 FDA actions in our database, including 23 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 Thermo Fisher Scientific have FDA actions?
Thermo Fisher Scientific has 23 FDA actions in our database, including 0 recalls and 23 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K243169" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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