DeviceClearance

Product code JQP— Clinical Chemistry

3388 REPORTING INTEGRATOR

Classification name
Calculator/Data Processing Module, For Clinical Use
Device class
Class 1
Regulation
21 CFR 862.2100
Advisory panel
Clinical Chemistry
Total cleared
78
First cleared
Most recent

Market context for product code JQP

FDA has cleared 78 devices under product code JQP between 1976 and 2012, filed by 45 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 JQP

Adverse events under product code JQP

product code JQP
Death
3
Malfunction
690
Total
693

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 JQP

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