Data / Medical devices / United States / Coagusense Inc
Coagusense Inc: FDA-registered device maker in Fremont, CA, United States, 5 510(k) clearances
Coagusense Inc is registered with the FDA (registration 3007507465) in Fremont, CA, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 5, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007507465
- Address
- 48377 Fremont Blvd Ste 113, Fremont, CA, United States, 94538
- Owner or operator
- Coagusense Inc (10029003)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- March 27, 2009
- Registered through
- 2026
- Brand names listed
- Assure PT Care PT/INR Monitoring System, Assure PT Care Test Strip Kit, 50 Count, Coag-Sense Portable Printer Paper, Bag of 5 Rolls (PD-99906), Coag-Sense Control Test Strip Kit - 10 (03P69-10), Coag-Sense PT/INR 6 Test Strip Kit w/ Transfer Tube (03P70-06), Coag-Sense PT/INR Monitoring System Patient Self Testing (03P70-03), Coag-Sense PT/INR Monitoring System Patient Self Testing (Self Care) (03P70-03), Coag-Sense PT/INR Professional 3-Box (06F73-03) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Multipurpose For In Vitro Coagulation Studies | JPA | 2 | Manufacturer | accessdata.fda.gov |
| Test, Time, Prothrombin | GJS | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 5, 2022 | K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | GJS | Substantially Equivalent | Coagusense, Inc. | accessdata.fda.gov |
| February 21, 2019 | K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | GJS | Substantially Equivalent | Coagusense, Inc. | accessdata.fda.gov |
| October 21, 2010 | K101145 | SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 | FMK | Substantially Equivalent | Medipurpose Pte. , Ltd. | accessdata.fda.gov |
| April 7, 2010 | K093243 | COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM | GJS | Substantially Equivalent | Coagusense, Inc. | accessdata.fda.gov |
| June 6, 2005 | K050243 | IMMEDIA PROTHROMBIN TIME SYSTEM | JPA | Substantially Equivalent | Farallon Medial, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Time, Prothrombin
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of System, Multipurpose For In Vitro Coagulation Studies
Updated October 5, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.