QQY — Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms Class II
FDA product code QQY covers "Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms", a Class II medical device regulated under 21 CFR 866.2190. 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
- 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.