LLG · Kit, Igg, Platelet Associated
Hematology · 21 CFR 864.5425 · Class 2
Overview
| Product Code | LLG |
|---|---|
| Device Name | Kit, Igg, Platelet Associated |
| Regulation | 21 CFR 864.5425 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K841465 | GENERAL DIAGNOSTICS PLATELET ANTIBODY | General Diagnostics | Jul 2, 1984 | SESE |
| K840257 | RAPID IMMUNO-ASSAY SYS | Applied Polytechnology, Inc. | Apr 19, 1984 | SESE |
Top Applicants
- Applied Polytechnology, Inc. — 1 clearance
- General Diagnostics — 1 clearance
