Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry
This device is a clinical chemistry system using ion-exchange columns combined with colorimetric detection to measure delta-aminolevulinic acid (ALA) in urine or other specimens, used as a marker for lead poisoning and porphyrin metabolism disorders. It is classified as FDA Class 1 and requires only general controls with no premarket notification. The product code is JKL, regulated under 21 CFR 862.1060, and assigned to the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JKL
- Device Class
- FDA class 1
- Regulation Number
- 862.1060
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.