DeviceClearance

Product code JSJ— Microbiology

SABOURAUD DEXTROSE AGAR

Classification name
Culture Media, Selective And Non-Differential
Device class
Class 1
Regulation
21 CFR 866.2360
Advisory panel
Microbiology
Total cleared
307
First cleared
Most recent

Market context for product code JSJ

FDA has cleared 307 devices under product code JSJ between 1976 and 1988, filed by 44 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 JSJ

Adverse events under product code JSJ

product code JSJ
Malfunction
520
Total
520

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 JSJ

1–100 of 307

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