GGO · Reagent, Thromboplastin And Control
Hematology · 21 CFR 864.7925 · Class 2
Overview
| Product Code | GGO |
|---|---|
| Device Name | Reagent, Thromboplastin And Control |
| Regulation | 21 CFR 864.7925 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K010158 | THROMBOMAX-HS WITH CALCIUM, MODEL T6540 | Sigma Diagnostics, Inc. | Mar 22, 2001 | SESE |
Top Applicants
- Sigma Diagnostics, Inc. — 1 clearance
