510(k) K172412
K172412 is an FDA 510(k) premarket notification submitted by Bacterioscan, Inc. for the device "BacterioScan 216Dx System". The FDA issued a decision of Substantially Equivalent on May 1, 2018. The device falls under product code QBQ (System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture), a Class I device regulated under 21 CFR 866.2560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2018
- Date Received
- August 10, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
- Device Class
- Class I
- Regulation Number
- 866.2560
- Review Panel
- MI
- Submission Type
Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium