LGP · Assay, Alpha-2-Antiplasmin
Hematology · 21 CFR 864.5425 · Class 2
Overview
| Product Code | LGP |
|---|---|
| Device Name | Assay, Alpha-2-Antiplasmin |
| 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K864213 | IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY | Instrumentation Laboratory CO | Nov 25, 1986 | SESE |
| K850411 | GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY | Warner-Lambert Co. | May 8, 1985 | SESE |
| K833890 | COATEST ANTIPLASMIN | Kabivitrum, Inc. | Jan 30, 1984 | SESE |
| K803110 | PROTEOLYTIC ENZYME CONTROL | American Dade | Feb 17, 1981 | SESE |
| K802840 | ALPHA-ANTIPLASM ASSAY | American Dade | Feb 17, 1981 | SESE |
Top Applicants
- American Dade — 2 clearances
- Instrumentation Laboratory CO — 1 clearance
- Kabivitrum, Inc. — 1 clearance
- Warner-Lambert Co. — 1 clearance
