DeviceClearance

Product code MCC— Microbiology

ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE

Classification name
Dna-Probe, Haemophilus Spp.
Device class
Class 2
Regulation
21 CFR 866.3300
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

Market context for product code MCC

FDA has cleared 2 devices under product code MCC, all in 1990, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code MCC

Recent clearances under product code MCC

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