SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
Device Facts
| Record ID | K003329 |
|---|---|
| Device Name | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | GGC · Hematology |
| Decision Date | Mar 1, 2001 |
| 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.
