SPECIALTY ASSAYED CONTROL-1
Device Facts
| Record ID | K941737 |
|---|---|
| Device Name | SPECIALTY ASSAYED CONTROL-1 |
| Applicant | Helena Laboratories |
| Product Code | GIZ · Hematology |
| Decision Date | Oct 7, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5425 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Special Controls
*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
