510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QQYClass II

Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms

21 CFR 866.2190 / Microbiology
FDA source (opens on fda.gov)

QQY is the FDA product code for Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms, a class II device type, regulated under 21 CFR 866.2190. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QQY
Device name
Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
FDA 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.
Regulation
21 CFR 866.2190
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QQY

By decision year
2 clearances under product code QQY with a decision year between 2021 and 2023, 2021 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QQY by decision year
YearClearances
20211
20231

Applicants with the most clearances

Product code QQY
Applicants holding the most 510(k) clearances under product code QQY
ApplicantClearances
BD Kiestra B.V.1
Clever Culture Systems Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code