BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)
FDA 510(k) K173252 · Becton, Dickinson and Company
510(k) numberK173252
Submission
- Device name
- BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)
- Applicant
- Becton, Dickinson and Company
Sparks, MD, US - Received
- October 10, 2017
- Decision date
- January 5, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1645
- Specialty
- Microbiology
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Questions and answers
When was BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) cleared by the FDA?
BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) (K173252) received a 510(k) decision of Substantially Equivalent on January 5, 2018, 87 days after the submission was received.
What is the product code of K173252?
The FDA product code is LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, a Class II (moderate risk) device regulated under 21 CFR 866.1645.