FDA product code GHO: Hemocytometer
GHO is the FDA product code for hemocytometer. It is a Class I device, regulated under 21 CFR 864.6160 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under GHO, from 2 different applicants. The average 510(k) review took 32 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Hemocytometer |
| Device class | Class I |
| Regulation | 21 CFR 864.6160 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Top GHO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Portable Medical Laboratories, Inc. | 1 | 1987-05-20 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1977-07-11 |
Most recent GHO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871671 | Portable Medical Laboratories, Inc. | URINOSCOPY FUNNEL | 1987-05-20 | 22 |
| K770980 | Bd Becton Dickinson Vacutainer Systems Preanalytic | EMATOLOGY DILUENT RESERVOIR CLOSURE | 1977-07-11 | 41 |
Recalls for GHO devices
openFDA lists no recalls for product code GHO.
Frequently asked questions
What is FDA product code GHO?
GHO is the FDA product code for hemocytometer. It is a Class I device, regulated under 21 CFR 864.6160 and reviewed by the Hematology panel.
What device class is GHO?
Class I, regulation 21 CFR 864.6160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GHO?
Across 2 cleared submissions the average was 32 days from receipt to decision (median 32).
Which companies have the most GHO clearances?
Portable Medical Laboratories, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GHO
- Run a recall and safety report across every GHO manufacturer
- Watch product code GHO 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.