FDA product code GIT: Reagent & Control, Partial Thromboplastin Time
GIT is the FDA product code for reagent & control, partial thromboplastin time. It is a Class II device, regulated under 21 CFR 864.7925 and reviewed by the Hematology panel. FDA has cleared 4 510(k) submissions under GIT, from 4 different applicants. The average 510(k) review took 52 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Reagent & Control, Partial Thromboplastin Time |
| Device class | Class II |
| Regulation | 21 CFR 864.7925 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GIT clearance
Top GIT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biotrack, Inc. | 1 | 1989-02-23 |
| Organon Teknika Corp. | 1 | 1988-08-17 |
| Creative Laboratory Products, Inc. | 1 | 1988-03-18 |
| Pacific Hemostasis | 1 | 1982-03-26 |
Most recent GIT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890051 | Biotrack, Inc. | BIOTRACK APTT CONTROLS | 1989-02-23 | 48 |
| K881999 | Organon Teknika Corp. | PLATELIN(R) EXCEL L | 1988-08-17 | 97 |
| K880711 | Creative Laboratory Products, Inc. | CLP 0.02 M CALCIUM CHLORIDE SOLUTION. | 1988-03-18 | 25 |
| K820450 | Pacific Hemostasis | THROMBOSCREEN | 1982-03-26 | 36 |
Recalls for GIT devices
openFDA lists no recalls for product code GIT.
Frequently asked questions
What is FDA product code GIT?
GIT is the FDA product code for reagent & control, partial thromboplastin time. It is a Class II device, regulated under 21 CFR 864.7925 and reviewed by the Hematology panel.
What device class is GIT?
Class II, regulation 21 CFR 864.7925. Typical premarket route: 510(k).
How long does a 510(k) take for product code GIT?
Across 4 cleared submissions the average was 52 days from receipt to decision (median 42).
Which companies have the most GIT clearances?
Biotrack, Inc. (1); Organon Teknika Corp. (1); Creative Laboratory Products, Inc. (1); Pacific Hemostasis (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GIT
- Run a recall and safety report across every GIT manufacturer
- Watch product code GIT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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