The following data is part of a premarket notification filed by Haemoscope Corp. with the FDA for Thrombelastograph(r).
| Device ID | K895844 |
| 510k Number | K895844 |
| Device Name: | THROMBELASTOGRAPH(R) |
| Classification | Instrument, Coagulation, Automated |
| Applicant | HAEMOSCOPE CORP. 5836 LINCOLN AVE. Morton Grove, IL 60053 |
| Contact | Zuckerman, Phd |
| Correspondent | Zuckerman, Phd 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 | 1989-10-03 |
| Decision Date | 1989-10-24 |