510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212779Substantially Equivalent

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing

Coagusense Inc, Fremont CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212779 is the FDA 510(k) clearance record for Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing, a class II device, cleared for Coagusense, Inc. on under FDA product code GJS (Test, Time, Prothrombin). FDA records list 3 510(k) clearances for Coagusense, Inc., from to . As of , FDA records show no recalls naming K212779.

Clearance record

Decision date
Received
(399 days to decision)
Product code
GJS Test, Time, Prothrombin
Regulation
21 CFR 864.7750
Device class
Class II
Review panel
Hematology
Applicant
Coagusense, Inc. 48377 Fremont Blvd. Suite 113, Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GJS

Trailing 12 months

FDA records hold no clearances under product code GJS in the trailing twelve months.

FDA records show no clearances under product code GJS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GJS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260