Product code CDH— Clinical Chemistry
URIC ACID
- Classification name
- Acid, Uric, Phosphotungstate Reduction
- Device class
- Class 1
- Regulation
- 21 CFR 862.1775
- Advisory panel
- Clinical Chemistry
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code CDH
FDA has cleared devices under product code CDH between 1976 and 1985, filed by 14 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1985
- 1984
- 1982
- 1981
- 1980
- 1979
- 1977
- 1976
Top applicants under product code CDH
Recent clearances under product code CDH
- K850933 — URIC ACID
- K841067 — URIC ACID REAGENT SET
- K821213 — URIC ACID REAGENT SET
- K813076 — PHOSPHOTUNGSTATE REDUCTION, URIC ACID
- K810088 — URIC ACID (TPTZ) COLORINMETRIC
- K800672 — SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
- K800190 — STANBIO DIRECT URIC ACID TEST SET #0770
- K792403 — ELVI URIC ACID-COLORIMETRIC METHOD
- K792412 — ELVI URIC ACID
- K790019 — SERUM, URIC ACID DETERMINATION
- K772082 — ENZAC URIC ACID 100-TEST KIT
- K771842 — URIC ACID
- K770564 — URIC ACID TEST KIT
- K770459 — URIC ACID PROCEDURE, TEKPOINT DIRECT
- K760477 — REAGENTS-4 FOR URIC ACID DETERMINATION
Data sourced from openFDA. This site is unofficial and independent of the FDA.