GIT · Reagent & Control, Partial Thromboplastin Time
Hematology · 21 CFR 864.7925 · Class 2
Overview
| Product Code | GIT |
|---|---|
| Device Name | Reagent & Control, Partial Thromboplastin Time |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890051 | BIOTRACK APTT CONTROLS | Biotrack, Inc. | Feb 23, 1989 | SESE |
| K881999 | PLATELIN(R) EXCEL L | Organon Teknika Corp. | Aug 17, 1988 | SESE |
| K880711 | CLP 0.02 M CALCIUM CHLORIDE SOLUTION. | Creative Laboratory Products, Inc. | Mar 18, 1988 | SESE |
| K820450 | THROMBOSCREEN | Pacific Hemostasis | Mar 26, 1982 | SESE |
Top Applicants
- Biotrack, Inc. — 1 clearance
- Creative Laboratory Products, Inc. — 1 clearance
- Organon Teknika Corp. — 1 clearance
- Pacific Hemostasis — 1 clearance
