Product code CDM— Clinical Chemistry
FITKIT I CHECKUP KIT
- Classification name
- Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- Device class
- Class 1
- Regulation
- 21 CFR 862.1785
- Advisory panel
- Clinical Chemistry
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code CDM
FDA has cleared devices under product code CDM between 1979 and 2006, filed by 8 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
- 2006
- 1988
- 1985
- 1983
- 1979
Top applicants under product code CDM
Recent clearances under product code CDM
- K052719 — URITEST 10 URINALYSIS REAGENT STRIPS
- K061559 — ACON URINALYSIS REAGENT STRIPS
- K880584 — URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C
- K873366 — WAKO(TM) PRETEST 5A
- K852611 — TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE
- K821799 — FITKIT I CHECKUP KIT
- K830340 — FITKIT I CHECKUP KIT
- K831623 — DIA STRIPS SYSTEM
- K790965 — REAGENT STRIPS FOR URINALYSIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.