FDA Product Code
FDA Product Code CDH — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1775
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K850933 | URIC ACID | Dilab, Inc. | 1985-06-25 | Traditional | PDF ↗ |
| K841067 | URIC ACID REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K821213 | URIC ACID REAGENT SET | Omega Medical Electronics | 1982-07-13 | Traditional | PDF ↗ |
| K813076 | PHOSPHOTUNGSTATE REDUCTION, URIC ACID | American Monitor Corp. | 1981-11-16 | Traditional | PDF ↗ |
| K810088 | URIC ACID (TPTZ) COLORINMETRIC | Bio-Analytics Laboratories, Inc. | 1981-01-28 | Traditional | PDF ↗ |
| K800672 | SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC | Diagnostic Solutions, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K800190 | STANBIO DIRECT URIC ACID TEST SET #0770 | Stanbio Laboratory | 1980-02-13 | Traditional | PDF ↗ |
| K792403 | ELVI URIC ACID-COLORIMETRIC METHOD | Volu Sol Medical Industries | 1979-12-07 | Traditional | PDF ↗ |
| K792412 | ELVI URIC ACID | Volu Sol Medical Industries | 1979-12-07 | Traditional | PDF ↗ |
| K790019 | SERUM, URIC ACID DETERMINATION | Fisher Scientific Co., LLC | 1979-02-26 | Traditional | PDF ↗ |
| K772082 | ENZAC URIC ACID 100-TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-11-28 | Traditional | PDF ↗ |
| K771842 | URIC ACID | Gamma Enterprises, Inc. | 1977-10-25 | Traditional | PDF ↗ |
| K770564 | URIC ACID TEST KIT | Mallinckrodt Critical Care | 1977-06-03 | Traditional | PDF ↗ |
| K770459 | URIC ACID PROCEDURE, TEKPOINT DIRECT | Icn Pharmaceuticals, Inc. | 1977-04-29 | Traditional | PDF ↗ |
| K760477 | REAGENTS-4 FOR URIC ACID DETERMINATION | Simmler & Son, Inc. | 1976-10-29 | Traditional | PDF ↗ |
Product code CDH · Class I · Clinical Chemistry. Data: openFDA.