Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
Summary
Coagusense, Inc. received 510(k) clearance for Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing, a GJS device. Cleared on 2022-10-05.
Details
Source
510(k) Clearance
External ID
K212779
Action Date
2022-10-05
Status
Special
Category
device
Product Code
GJS
Product Description
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing. Product code: GJS.
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.
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 Coagusense, Inc. have FDA actions?
This is the only FDA action we have on record for Coagusense, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212779" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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