JBN · Fibrin Monomer Paracoagulation
Hematology · 21 CFR 864.7300 · Class 2
Overview
| Product Code | JBN |
|---|---|
| Device Name | Fibrin Monomer Paracoagulation |
| Regulation | 21 CFR 864.7300 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. The special control for this device is FDA's “In Vitro Diagnostic Fibrin Monomer Paracoagulation Test.” See § 864.1(d) for information on obtaining this document.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K854015 | FS TEST KIT | American Bioproducts Co. | Mar 6, 1986 | SESE |
| K781814 | SULFATE, FIBRIQUIK PROTAMINE | General Diagnostics | Nov 8, 1978 | SESE |
Top Applicants
- American Bioproducts Co. — 1 clearance
- General Diagnostics — 1 clearance
