MCC — Dna-Probe, Haemophilus Spp. Class II

FDA Device Classification

FDA product code MCC covers "Dna-Probe, Haemophilus Spp.", a Class II medical device regulated under 21 CFR 866.3300. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MCC
Device Class
Class II
Regulation Number
866.3300
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K901397gen-probeACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.June 20, 1990
K897079gen-probeACCUPROBE HAEOMPHILUS INFLUENZAE CULTUREMarch 8, 1990