MLA — Dna Probe, Yeast Class I

FDA Device Classification

FDA product code MLA covers "Dna Probe, Yeast", a Class I medical device regulated under 21 CFR 866.2660. 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
MLA
Device Class
Class I
Regulation Number
866.2660
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K931151microprobeAFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDAJune 18, 1993
K931374microprobeAFFIRM VPIII MICROBIAL IDENTIFICATION TESTJune 15, 1993