Assay, Carboxyhemoglobin
Assay, Carboxyhemoglobin (product code GHS) is a hematology test used to measure the concentration of carboxyhemoglobin in blood, a form of hemoglobin bound to carbon monoxide, supporting the diagnosis and monitoring of carbon monoxide poisoning. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7425 in the Hematology specialty (HE), it is eligible for third-party review.
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Basic Information
- Product Code
- GHS
- Device Class
- FDA class 2
- Regulation Number
- 864.7425
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K974805 | CO-STAT(TM) END TIDAL BREATH ANALYZER | Mar 11, 1998 | Substantially Equivalent | Natus Medical, Inc. |
| K910827 | ABL520 BLOOD GAS SYSTEM | Jul 09, 1991 | Substantially Equivalent | Radiometer America, Inc. |
| K790943 | TRISEDTA-BORATE ELECTROPHORESIS FILM AGA | Jun 22, 1979 | Substantially Equivalent | Corning Medical & Scientific |
| K771263 | RADIOMHTER OSM-2 HEMOXIMETER | Aug 03, 1977 | Substantially Equivalent | The London Co. |
| K770209 | ECOLYZER CARBOXIMETER | Mar 07, 1977 | Substantially Equivalent | Iadec, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.