21 CFR 864.5400 — Fibrometer
Hematology (HE) · Part 864 Subpart F—Automated and Semi-Automated Hematology Devices · § 864.5400
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GIE | Fibrometer | 2 | 2 | |
| GKN | Timer, Clot, Automated | 2 | 3 | 3rd Party |
| GKP | Instrument, Coagulation, Automated | 2 | 49 | 3rd Party |
| JBT | Timer, Coagulation | 2 | 0 | |
| KQG | Instrument, Coagulation | 2 | 14 | 3rd Party |
Special Controls
GIE — Fibrometer
*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.
eCFR
GKN — Timer, Clot, Automated
*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.
eCFR
GKP — Instrument, Coagulation, Automated
*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.
eCFR
JBT — Timer, Coagulation
*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.
eCFR
KQG — Instrument, Coagulation
*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.
eCFR
