DeviceClearance

Product code KXF— General Hospital

ALLERGEAZE PATCH TEST CHAMBERS

Classification name
Applicator, Absorbent Tipped, Non-Sterile
Device class
Class 1
Regulation
21 CFR 880.6025
Advisory panel
General Hospital
Total cleared
21
First cleared
Most recent

Market context for product code KXF

FDA has cleared 21 devices under product code KXF between 1977 and 2012, filed by 16 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 KXF

Adverse events under product code KXF

product code KXF
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code KXF

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