FDA product code GIE: Fibrometer
GIE is the FDA product code for fibrometer. It is a Class II device, regulated under 21 CFR 864.5400 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under GIE. The average 510(k) review took 37 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Fibrometer |
| Device class | Class II |
| Regulation | 21 CFR 864.5400 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GIE clearance
Top GIE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Scientific Products | 2 | 1982-04-08 |
Most recent GIE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K820533 | American Scientific Products | B4182-1 | 1982-04-08 | 37 |
| K820532 | American Scientific Products | DISPO FIBRIN PIPET TIPS B4182-2 | 1982-04-08 | 37 |
Recalls for GIE devices
openFDA lists no recalls for product code GIE.
Frequently asked questions
What is FDA product code GIE?
GIE is the FDA product code for fibrometer. It is a Class II device, regulated under 21 CFR 864.5400 and reviewed by the Hematology panel.
What device class is GIE?
Class II, regulation 21 CFR 864.5400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GIE?
Across 2 cleared submissions the average was 37 days from receipt to decision (median 37).
Which companies have the most GIE clearances?
American Scientific Products (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GIE
- Run a recall and safety report across every GIE manufacturer
- Watch product code GIE 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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