SAS BRUCELLA MELITENSIS ANTISERUM
FDA 510(k) clearance K952143 · decided 1995-07-21
Clearance details
- K-number
- K952143
- Device name
- SAS BRUCELLA MELITENSIS ANTISERUM
- Applicant
- Sa Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-08
- Decision date
- 1995-07-21
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- GSM
- Device class
- 2
- Regulation number
- 866.3085
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SAS BRUCELLAS ABORTUS ANTISERUM (K952146) | Sa Scientific, Inc. | 1995-07-21 |
| SAS BRUCELLA SUIS ANTISERUM (K952144) | Sa Scientific, Inc. | 1995-07-21 |
| SAS BRUCELLA AMS ANTISERUM (K952132) | Sa Scientific, Inc. | 1995-07-21 |
Recalls involving this device
No recalls on record reference this clearance.