SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
FDA 510(k) clearance K061496 · decided 2007-06-28
Clearance details
- K-number
- K061496
- Device name
- SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
- Applicant
- Sa Scientific , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-31
- Decision date
- 2007-06-28
- Days to decision
- 393 days
- Clearance type
- Traditional
- Product code
- MJH
- Device class
- 2
- Regulation number
- 866.3300
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.