Coagusense Inc
Fremont, CA, US
COAGUSENSE INC appears in FDA device records in Fremont, CA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Coagusense Inc between 2010 and 2022. The busiest year on record is 2010, with 1. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | GJS | Substantially Equivalent | |
| K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | GJS | Substantially Equivalent | |
| K093243 | COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM | GJS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007507465 | 3007507465 | COAGUSENSE INC | 48377 Fremont Blvd Ste 113, Fremont, CA 94538 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain