K895844 is an FDA 510(k) clearance for the THROMBELASTOGRAPH(R). This device is classified as a Instrument, Coagulation, Automated (Class II - Special Controls, product code GKP).
Submitted by Haemoscope Corp. (Morton Grove, US). The FDA issued a Cleared decision on October 24, 1989, 21 days after receiving the submission on October 3, 1989.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5400.
| 510(k) Number | K895844 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 1989 |
| Decision Date | October 24, 1989 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GKP — Instrument, Coagulation, Automated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5400 |