FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML
K Number: K052250
·
Decision Sep 30, 2005
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
284
Applicant Total
113
Review Days
43
Basic Information
- Device Name
- BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML
- K Number
- K052250
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1645
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BECTON, DICKINSON & CO.
- Date Received
- August 18, 2005
- Decision Date
- September 30, 2005
- Product Code
- LON
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | FDA class 2 | Microbiology |
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| K091730 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | Nov 13, 2009 | Substantially Equivalent |
| K090971 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | Jun 5, 2009 | Substantially Equivalent |
| K090824 | BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY | Jun 2, 2009 | Substantially Equivalent |
| K090827 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | May 27, 2009 | Substantially Equivalent |
| K082852 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML | Jan 29, 2009 | Substantially Equivalent |