FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
K Number: K123903
·
Decision May 13, 2013
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
67
Applicant Total
190
Review Days
145
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Basic Information
- Device Name
- BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
- K Number
- K123903
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2560
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton, Dickinson & CO
- Date Received
- December 19, 2012
- Decision Date
- May 13, 2013
- Product Code
- MDB
- 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 |
|---|---|---|---|
| MDB | System, Blood Culturing | FDA class 1 | Microbiology |
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