Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
This device is a spectral absorbance curve measurement system used to distinguish and quantify oxyhemoglobin and carboxyhemoglobin in blood specimens, supporting the diagnosis of carbon monoxide poisoning by identifying the characteristic shift in hemoglobin absorbance spectra caused by CO binding. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls with no premarket submission. The product code is JKS, regulated under 21 CFR 862.3220, within the Clinical Toxicology medical specialty.
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Basic Information
- Product Code
- JKS
- Device Class
- FDA class 1
- Regulation Number
- 862.3220
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K951485 | AVOXIMETER 4000 | Nov 06, 1995 | Substantially Equivalent | A-Vox Systems, Inc. |
| K863825 | CO-OXIMETER SOLUTIONS | Nov 24, 1986 | Substantially Equivalent | D.R.G. Scientific Industries |
| K862253 | IL 482 CO-OXIMETER | Jul 29, 1986 | Substantially Equivalent | Instrumentation Laboratory CO |
| K853990 | OSM3 HEMOXIMETER | Dec 30, 1985 | Substantially Equivalent | Radiometer America, Inc. |
| K833693 | TEE ADAPTER 9890-FLUSH WINDING 282 | Dec 30, 1983 | Substantially Equivalent | Shaban Mfg. Co. |
| K833211 | BILE SALTS MIXTURE | Oct 27, 1983 | Substantially Equivalent | Acumedia Manufacturers, Inc. |
| K832066 | CONTROL 282 | Sep 29, 1983 | Substantially Equivalent | Bio-Nustics, Inc. |
| K780652 | HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 | Jul 27, 1978 | Substantially Equivalent | The London Co. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.