DeviceClearance

Product code JJE— Clinical Chemistry

ATAC 6000 CHEMISTRY ANALYZER

Classification name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class
Class 1
Regulation
21 CFR 862.2160
Advisory panel
Clinical Chemistry
Total cleared
208
First cleared
Most recent

Market context for product code JJE

FDA has cleared 208 devices under product code JJE between 1976 and 2019, filed by 99 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 JJE

Adverse events under product code JJE

product code JJE
Death
6
Injury
441
Malfunction
25,011
Other
1
Total
25,459

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 JJE

1–100 of 208

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