DeviceClearance

Product code CKA— Clinical Chemistry

ULTRAZYME PLUS GPT

Classification name
Nadh Oxidation/Nad Reduction, Alt/Sgpt
Device class
Class 1
Regulation
21 CFR 862.1030
Advisory panel
Clinical Chemistry
Total cleared
127
First cleared
Most recent

Market context for product code CKA

FDA has cleared 127 devices under product code CKA between 1976 and 2013, filed by 76 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

last 15 years

Top applicants under product code CKA

Recent clearances under product code CKA

1–100 of 127

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