Acid, Uric, Acid Reduction Of Ferric Ion
The uric acid test using acid reduction of ferric ion is a clinical chemistry laboratory method that measures uric acid concentrations in biological specimens based on the reduction of ferric ions, used to evaluate gout, renal function, and purine metabolism disorders. The device is FDA Class 1, the lowest risk category, subject only to general controls and not requiring premarket notification. It carries product code LFQ and is regulated under 21 CFR 862.1775 within the Clinical Chemistry specialty. No special flags apply to this device.
Research product code LFQ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- LFQ
- Device Class
- FDA class 1
- Regulation Number
- 862.1775
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K860111 | URIC ACID REAGENT SET | Feb 19, 1986 | Substantially Equivalent | Technostics Intl. |
| K860142 | URIC ACID REAGENT SET (COLORIMETRIC) | Feb 11, 1986 | Substantially Equivalent | Sterling Diagnostics, Inc. |
| K844075 | URIC ACID REAGENT SET | Oct 30, 1984 | Substantially Equivalent | Livonia Diagnostics, Inc. |
| K812313 | SANDARE URIC ACID PROCEDURE | Sep 01, 1981 | Substantially Equivalent | Sandare Chemical Co., Inc. |
| K811764 | URIC ACID REAGENT SET | Aug 20, 1981 | Substantially Equivalent | Anco Medical Reagents & Assoc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.