QBQ — System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture Class I
FDA product code QBQ covers "System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture", a Class I medical device regulated under 21 CFR 866.2560. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QBQ
- Device Class
- Class I
- Regulation Number
- 866.2560
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172412 | bacterioscan | BacterioScan 216Dx System | May 1, 2018 |