Acid, Ferric Ion-Sulfuric, Cholesterol
The Ferric Ion-Sulfuric Acid, Cholesterol test system (product code CHD) is an in-vitro diagnostic device used in clinical chemistry to measure total cholesterol in serum or plasma using a ferric ion and sulfuric acid colorimetric reaction. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1175 in the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- CHD
- Device Class
- FDA class 1
- Regulation Number
- 862.1175
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K841052 | CHOLESTEROL REAGENT SET | May 01, 1984 | Substantially Equivalent | Medical Specialties, Inc. |
| K830616 | ACTIVATED URIC ACID | Apr 05, 1983 | Substantially Equivalent | American Monitor Corp. |
| K821195 | CHOLESTEROL REAGENT SET | Jul 13, 1982 | Substantially Equivalent | Omega Medical Electronics |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.