Reagent & Control, Partial Thromboplastin Time
Reagent and Control, Partial Thromboplastin Time (product code GIT) is a paired hematology reagent and quality control system used to perform and validate the partial thromboplastin time (PTT) assay, which screens the intrinsic coagulation pathway and monitors heparin therapy. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7925 in the Hematology specialty (HE), it is eligible for third-party review.
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Basic Information
- Product Code
- GIT
- Device Class
- FDA class 2
- Regulation Number
- 864.7925
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K890051 | BIOTRACK APTT CONTROLS | Feb 23, 1989 | Substantially Equivalent | Biotrack, Inc. |
| K881999 | PLATELIN(R) EXCEL L | Aug 17, 1988 | Substantially Equivalent | Organon Teknika Corp. |
| K880711 | CLP 0.02 M CALCIUM CHLORIDE SOLUTION. | Mar 18, 1988 | Substantially Equivalent | Creative Laboratory Products, Inc. |
| K820450 | THROMBOSCREEN | Mar 26, 1982 | Substantially Equivalent | Pacific Hemostasis |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.