DeviceClearance

Product code KPA— Pathology

AUTO. SLIDE STAINER

Classification name
Slide Stainer, Automated
Device class
Class 1
Regulation
21 CFR 864.3800
Advisory panel
Pathology
Total cleared
21
First cleared
Most recent

Market context for product code KPA

FDA has cleared 21 devices under product code KPA between 1977 and 1994, filed by 15 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 KPA

Adverse events under product code KPA

product code KPA
Malfunction
1,177
Total
1,177

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 KPA

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