DeviceClearance

Product code JJX— Clinical Chemistry

DADE TRU-LIQUID CARDIAC CONTROL

Classification name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device class
Class 1
Regulation
21 CFR 862.1660
Advisory panel
Clinical Chemistry
Total cleared
493
First cleared
Most recent

Market context for product code JJX

FDA has cleared 493 devices under product code JJX between 1976 and 2017, filed by 145 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 JJX

Adverse events under product code JJX

product code JJX
Other
2
Total
2

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 JJX

1–100 of 493

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