COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE
FDA 510(k) clearance K070062 · decided 2007-07-30
Clearance details
- K-number
- K070062
- Device name
- COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE
- Applicant
- Diesse Diagnostica Senese S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-05
- Decision date
- 2007-07-30
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- LIO
- Device class
- 1
- Regulation number
- 866.2900
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Hialeah, FL, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.