The following data is part of a premarket notification filed by Hemosense, Inc. with the FDA for Inratio.
Device ID | K020679 |
510k Number | K020679 |
Device Name: | INRATIO |
Classification | Test, Time, Prothrombin |
Applicant | HEMOSENSE, INC. 600 VALLEY WAY Milpitas, CA 95035 |
Contact | Judith Blunt |
Correspondent | Judith Blunt HEMOSENSE, INC. 600 VALLEY WAY Milpitas, CA 95035 |
Product Code | GJS |
CFR Regulation Number | 864.7750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-04 |
Decision Date | 2002-05-06 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INRATIO 75800851 2779799 Live/Registered |
ALERE SAN DIEGO, INC. 1999-09-15 |