FDA product code GHS: Assay, Carboxyhemoglobin
GHS is the FDA product code for assay, carboxyhemoglobin. It is a Class II device, regulated under 21 CFR 864.7425 and reviewed by the Hematology panel. FDA has cleared 5 510(k) submissions under GHS, from 5 different applicants. The average 510(k) review took 61 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Assay, Carboxyhemoglobin |
| Device class | Class II |
| Regulation | 21 CFR 864.7425 |
| 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 GHS clearance
Top GHS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Natus Medical, Inc. | 1 | 1998-03-11 |
| Radiometer America, Inc. | 1 | 1991-07-09 |
| Corning Medical & Scientific | 1 | 1979-06-22 |
| The London Co. | 1 | 1977-08-03 |
| Iadec, Inc. | 1 | 1977-03-07 |
Most recent GHS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974805 | Natus Medical, Inc. | CO-STAT(TM) END TIDAL BREATH ANALYZER | 1998-03-11 | 78 |
| K910827 | Radiometer America, Inc. | ABL520 BLOOD GAS SYSTEM | 1991-07-09 | 132 |
| K790943 | Corning Medical & Scientific | TRISEDTA-BORATE ELECTROPHORESIS FILM AGA | 1979-06-22 | 35 |
| K771263 | The London Co. | RADIOMHTER OSM-2 HEMOXIMETER | 1977-08-03 | 23 |
| K770209 | Iadec, Inc. | ECOLYZER CARBOXIMETER | 1977-03-07 | 35 |
Recalls for GHS devices
openFDA lists no recalls for product code GHS.
Frequently asked questions
What is FDA product code GHS?
GHS is the FDA product code for assay, carboxyhemoglobin. It is a Class II device, regulated under 21 CFR 864.7425 and reviewed by the Hematology panel.
What device class is GHS?
Class II, regulation 21 CFR 864.7425. Typical premarket route: 510(k).
How long does a 510(k) take for product code GHS?
Across 5 cleared submissions the average was 61 days from receipt to decision (median 35).
Which companies have the most GHS clearances?
Natus Medical, Inc. (1); Radiometer America, Inc. (1); Corning Medical & Scientific (1); The London Co. (1); Iadec, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GHS
- Run a recall and safety report across every GHS manufacturer
- Watch product code GHS 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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