Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms

QQY · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.2190

Classification

FDA Product Code: QQY
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.2190
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Culture plate imaging system for qualitative assessment of resistant organisms is an automated system to assess the presence or absence of colony growth on solid chromogenic culture media.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 4

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown