The following data is part of a premarket notification filed by Haemoscope Corp. with the FDA for Thrombelastograph.
Device ID | K904204 |
510k Number | K904204 |
Device Name: | THROMBELASTOGRAPH |
Classification | Instrument, Coagulation, Automated |
Applicant | HAEMOSCOPE CORP. 5836 LINCOLN AVE. Morton Grove, IL 60053 |
Contact | Leon Zuckerman |
Correspondent | Leon Zuckerman HAEMOSCOPE CORP. 5836 LINCOLN AVE. Morton Grove, IL 60053 |
Product Code | GKP |
CFR Regulation Number | 864.5400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-12 |
Decision Date | 1990-11-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THROMBELASTOGRAPH 72077539 0710559 Live/Registered |
HAEMOSCOPE CORPORATION 1959-07-13 |