QQY — Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms Class II

FDA Device Classification

Classification Details

Product Code: QQY
Device Class: Class II
Regulation Number: 866.2190
Submission Type
Review Panel: MI
Medical Specialty: Microbiology
Implant: No

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K213280	bd kiestra	BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD K	May 4, 2023
K200839	clever culture systems	APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence	October 28, 2021