SAS FRANCISELLA TULARENSIS ANTIGEN
FDA 510(k) clearance K952138 · decided 1995-07-17
Clearance details
- K-number
- K952138
- Device name
- SAS FRANCISELLA TULARENSIS ANTIGEN
- Applicant
- Sa Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-08
- Decision date
- 1995-07-17
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- GSL
- Device class
- 2
- Regulation number
- 866.3280
- 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.