Product code KLH— Microbiology

OXYMETER & TRANSOXODE

Classification name
Antisera, C. Acnes
Device class
Class 1
Regulation
21 CFR 866.3140
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

Market context for product code KLH

FDA has cleared 1 device under product code KLH, all in 1980, 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 KLH

Recent clearances under product code KLH

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