Product code MJK— Microbiology

AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA

Classification name
Dna Probe, Trichomonas Vaginalis
Device class
Class 1
Regulation
21 CFR 866.2660
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

Market context for product code MJK

FDA has cleared 1 device under product code MJK, all in 1992, filed by 1 applicant company. 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.

Top applicants under product code MJK

Recent clearances under product code MJK

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