LQH — Dna-Reagents, Legionella Class II

FDA Device Classification

FDA product code LQH covers "Dna-Reagents, Legionella", 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
LQH
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
K033861becton, dickinson andBD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAYMarch 9, 2004
K860498gen-probeGEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEMJuly 16, 1986