Product code CDF— Clinical Chemistry
HELENA VMA-SMC COLUMN METHOD
- Classification name
- Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
- Device class
- Class 1
- Regulation
- 21 CFR 862.1795
- Advisory panel
- Clinical Chemistry
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code CDF
FDA has cleared devices under product code CDF between 1977 and 1996, filed by 9 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
- 1996
- 1994
- 1989
- 1987
- 1986
- 1985
- 1984
- 1981
- 1979
- 1977
Top applicants under product code CDF
Recent clearances under product code CDF
- K953077 — PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM
- K934977 — MODEL 5500 CEAS
- K895288 — HVA EIA KIT YAMASA
- K895287 — VMA EIA KIT YAMASA
- K873372 — HVA & HOMOVANILLIC ACID BY HPLC METHOD
- K861962 — VANILMANDELIC ACID (VMA) REAGENT SET
- K861010 — VMA BY HPLC TEST (VANILMANDELIC ACID)
- K853041 — TRIGLYCERIDES LCK 124
- K843379 — VMA ASSAY KIT
- K810992 — HELENA VMA-SMC COLUMN METHOD
- K791837 — VMA BY COLUMN TEST
- K772151 — URINARY VMA - SCREEN TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.