CDH
15 FDA 510(k) clearances · Product code
50 daysmedian time to decision
77 days90th percentile
15clearances measured
FDA profile
- Official device name
- Acid, Uric, Phosphotungstate Reduction
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1775
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| URIC ACID (K850933) | Dilab, Inc. | 1985-06-25 |
| URIC ACID REAGENT SET (K841067) | Medical Specialties, Inc. | 1984-05-01 |
| URIC ACID REAGENT SET (K821213) | Omega Medical Electronics | 1982-07-13 |
| PHOSPHOTUNGSTATE REDUCTION, URIC ACID (K813076) | American Monitor Corp. | 1981-11-16 |
| URIC ACID (TPTZ) COLORINMETRIC (K810088) | Bio-Analytics Laboratories, Inc. | 1981-01-28 |
| SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC (K800672) | Diagnostic Solutions, Inc. | 1980-05-28 |
| STANBIO DIRECT URIC ACID TEST SET #0770 (K800190) | Stanbio Laboratory | 1980-02-13 |
| ELVI URIC ACID (K792412) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI URIC ACID-COLORIMETRIC METHOD (K792403) | Volu Sol Medical Industries | 1979-12-07 |
| SERUM, URIC ACID DETERMINATION (K790019) | Fisher Scientific Co., LLC | 1979-02-26 |
| ENZAC URIC ACID 100-TEST KIT (K772082) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-11-28 |
| URIC ACID (K771842) | Gamma Enterprises, Inc. | 1977-10-25 |
| URIC ACID TEST KIT (K770564) | Mallinckrodt Critical Care | 1977-06-03 |
| URIC ACID PROCEDURE, TEKPOINT DIRECT (K770459) | Icn Pharmaceuticals, Inc. | 1977-04-29 |
| REAGENTS-4 FOR URIC ACID DETERMINATION (K760477) | Simmler & Son, Inc. | 1976-10-29 |
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Every clearance here is in the API, with alerts when new ones post.