THROMBELASTOGRAPH
Instrument, Coagulation, Automated
HAEMOSCOPE CORP.
The following data is part of a premarket notification filed by Haemoscope Corp. with the FDA for Thrombelastograph.
Pre-market Notification Details
| 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 |
Trademark Results [THROMBELASTOGRAPH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THROMBELASTOGRAPH 72077539 0710559 Live/Registered |
HAEMOSCOPE CORPORATION 1959-07-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.