Product code HYW— Hematology

DROPPER, SOLUTION TRICHROME, CEPTI-SEAL

Classification name
Stain, Trichrome, Mallory'S
Device class
Class 1
Regulation
21 CFR 864.1850
Advisory panel
Hematology
Total cleared
2
First cleared
Most recent

Market context for product code HYW

FDA has cleared 2 devices under product code HYW between 1978 and 1980, filed by 2 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

Top applicants under product code HYW

Recent clearances under product code HYW

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