Product code MCT— Microbiology

ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR.

Classification name
Dna-Probe, Strep Pneumoniae
Device class
Class 1
Regulation
21 CFR 866.3740
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

Market context for product code MCT

FDA has cleared 1 device under product code MCT, all in 1990, 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 MCT

Recent clearances under product code MCT

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