SAS SALMONELLA H C ANTISERUM
FDA 510(k) clearance K952288 · decided 1995-07-25
Clearance details
- K-number
- K952288
- Device name
- SAS SALMONELLA H C ANTISERUM
- Applicant
- Sa Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-16
- Decision date
- 1995-07-25
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- GRM
- Device class
- 2
- Regulation number
- 866.3550
- 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 SALMONELLA H Z4, Z24 ANTISERUM (K961960) | Sa Scientific, Inc. | 1996-06-18 |
| SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS (K961952) | Sa Scientific, Inc. | 1996-06-18 |
| SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM (K961963) | Sa Scientific, Inc. | 1996-06-18 |
| SAS SALMONELLA O POLY B ANTISERUM (K961967) | Sa Scientific, Inc. | 1996-06-18 |
| SAS SALMONELLA H Z4, Z32 ANTISERUM (K961957) | Sa Scientific, Inc. | 1996-06-18 |
| SAS SALMONELLA O FACTOR 6 ANTISERUM (K961951) | Sa Scientific, Inc. | 1996-06-18 |
| SAS SALMONELLA H G,M,Q ANTISERMU (K961956) | Sa Scientific, Inc. | 1996-06-18 |
| SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM (K961962) | Sa Scientific, Inc. | 1996-06-18 |
| SAS SALMONELLA O FACTOR 20 ANTISERUM (K961948) | Sa Scientific, Inc. | 1996-06-18 |
| SAS SALMONELLA H Z4 COMPLEX ANTISERUM (K961958) | Sa Scientific, Inc. | 1996-06-18 |
| SAS SALMONELLA H F,G,T ANTISERUM (K961961) | Sa Scientific, Inc. | 1996-06-18 |
| SAS SALMONELLA H Z35 ANTISERUM (K961954) | Sa Scientific, Inc. | 1996-06-18 |
Recalls involving this device
No recalls on record reference this clearance.