Product code KKK— Hematology

SUDAN IV HERXHEIMER

Classification name: Sudan Iv
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Total cleared: 1
First cleared: 1984-09-11
Most recent: 1984-09-11

Market context for product code KKK

FDA has cleared 1 device under product code KKK, all in 1984, filed by 1 applicant company. 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.

Top applicants under product code KKK

E K Ind., Inc.1 clearance

Recent clearances under product code KKK

K842916 — SUDAN IV HERXHEIMERE K Ind., Inc.·1984-09-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.