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

System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture

21 CFR 866.2560 / Microbiology
FDA source (opens on fda.gov)

QBQ is the FDA product code for System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture, a class I device type, regulated under 21 CFR 866.2560. FDA's definition for this code reads: "Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QBQ
Device name
System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
FDA definition
Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium
Regulation
21 CFR 866.2560
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QBQ

By decision year
1 clearance under product code QBQ with a decision year between 2018 and 2018, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QBQ by decision year
YearClearances
20181

Applicants with the most clearances

Product code QBQ
Applicants holding the most 510(k) clearances under product code QBQ
ApplicantClearances
Bacterioscan, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QBQ.