BD Phoenix Automated Microbiology System-Pipercillin (GN) 0.5-128 Ug/Ml
FDA 510(k) K041572 · Becton, Dickinson and Co.
510(k) numberK041572
Submission
- Device name
- BD Phoenix Automated Microbiology System-Pipercillin (GN) 0.5-128 Ug/Ml
- Applicant
- Becton, Dickinson and Co.
Sparks, MD, US - Received
- June 14, 2004
- Decision date
- August 12, 2004
- 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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| K232756 | ColibríLON · Traditional | Copan Wasp Srl | 12/27/2023SE |
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Questions and answers
When was BD Phoenix Automated Microbiology System-Pipercillin (GN) 0.5-128 Ug/Ml cleared by the FDA?
BD Phoenix Automated Microbiology System-Pipercillin (GN) 0.5-128 Ug/Ml (K041572) received a 510(k) decision of Substantially Equivalent on August 12, 2004, 59 days after the submission was received.
What is the product code of K041572?
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.