CDH — Acid, Uric, Phosphotungstate Reduction Class I
FDA product code CDH covers "Acid, Uric, Phosphotungstate Reduction", a Class I medical device regulated under 21 CFR 862.1775. Submissions are reviewed by the Clinical Chemistry panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CDH
- Device Class
- Class I
- Regulation Number
- 862.1775
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K850933 | dilab | URIC ACID | June 25, 1985 |
| K841067 | medical specialties | URIC ACID REAGENT SET | May 1, 1984 |
| K821213 | omega medical electronics | URIC ACID REAGENT SET | July 13, 1982 |
| K813076 | american monitor | PHOSPHOTUNGSTATE REDUCTION, URIC ACID | November 16, 1981 |
| K810088 | bio-analytics laboratories | URIC ACID (TPTZ) COLORINMETRIC | January 28, 1981 |
| K800672 | diagnostic solutions | SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC | May 28, 1980 |
| K800190 | stanbio laboratory | STANBIO DIRECT URIC ACID TEST SET #0770 | February 13, 1980 |
| K792403 | volu sol medical industries | ELVI URIC ACID-COLORIMETRIC METHOD | December 7, 1979 |
| K792412 | volu sol medical industries | ELVI URIC ACID | December 7, 1979 |
| K790019 | fisher scientific co | SERUM, URIC ACID DETERMINATION | February 26, 1979 |
| K772082 | bd becton dickinson vacutainer systems preanalytic | ENZAC URIC ACID 100-TEST KIT | November 28, 1977 |
| K771842 | gamma enterprises | URIC ACID | October 25, 1977 |
| K770564 | mallinckrodt critical care | URIC ACID TEST KIT | June 3, 1977 |
| K770459 | icn pharmaceuticals | URIC ACID PROCEDURE, TEKPOINT DIRECT | April 29, 1977 |
| K760477 | simmler and son | REAGENTS-4 FOR URIC ACID DETERMINATION | October 29, 1976 |