Conversion To Creatinine, Creatine
This device is a clinical chemistry reagent system that measures creatine by first converting it to creatinine, then applying a colorimetric or photometric method, used in the assessment of muscle metabolism and renal function in clinical laboratories. It is classified as FDA Class 1, the lowest risk category, requiring only general controls without a premarket notification. The product code is JLA, regulated under 21 CFR 862.1210, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JLA
- Device Class
- FDA class 1
- Regulation Number
- 862.1210
- 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 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.