ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT
Device Facts
| Record ID | K941001 |
|---|---|
| Device Name | ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT |
| Applicant | Diagnostic Specialties |
| Product Code | GIS · Hematology |
| Decision Date | Aug 30, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7340 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).
Special Controls
*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
