GIE · Fibrometer
Hematology · 21 CFR 864.5400 · Class 2
Overview
| Product Code | GIE |
|---|---|
| Device Name | Fibrometer |
| Regulation | 21 CFR 864.5400 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.
Classification Rationale
Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K820533 | B4182-1 | American Scientific Products | Apr 8, 1982 | SESE |
| K820532 | DISPO FIBRIN PIPET TIPS B4182-2 | American Scientific Products | Apr 8, 1982 | SESE |
Top Applicants
- American Scientific Products — 2 clearances
