BD VIPER SYSTEM
FDA 510(k) clearance K052481 · decided 2005-11-28
Clearance details
- K-number
- K052481
- Device name
- BD VIPER SYSTEM
- Applicant
- Becton, Dickinson & CO
- Decision
- Substantially Equivalent
- Date received
- 2005-09-09
- Decision date
- 2005-11-28
- Days to decision
- 80 days
- Clearance type
- Special
- Product code
- LSL
- Device class
- 2
- Regulation number
- 866.3390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sparks, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.