SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML)
FDA 510(k) clearance K961528 · decided 1996-05-20
Clearance details
- K-number
- K961528
- Device name
- SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML)
- Applicant
- Sa Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-22
- Decision date
- 1996-05-20
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- GNB
- Device class
- 2
- Regulation number
- 866.3660
- 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 SHIGELLA SONNEI FORM II ANTISERUM (K961537) | Sa Scientific, Inc. | 1996-05-31 |
| SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM (K961551) | Sa Scientific, Inc. | 1996-05-20 |
| SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM (K961532) | Sa Scientific, Inc. | 1996-05-20 |
| SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM (K961546) | Sa Scientific, Inc. | 1996-05-20 |
| SAS SHIGELLA BOYDII TYPE 12 ANTISERUM (K961529) | Sa Scientific, Inc. | 1996-05-20 |
| SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM (K961535) | Sa Scientific, Inc. | 1996-05-20 |
| SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) (K961534) | Sa Scientific, Inc. | 1996-05-20 |
| SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM (K961549) | Sa Scientific, Inc. | 1996-05-20 |
| SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM (K961538) | Sa Scientific, Inc. | 1996-05-20 |
| SAS SHIGELLA BOYDII TYPE 10 ANTISERUM (K961554) | Sa Scientific, Inc. | 1996-05-20 |
| SAS SHIGELLA BOYDII TYPE 15 ANTISERUM (K961548) | Sa Scientific, Inc. | 1996-05-20 |
| SAS SHIGELLA BOYDII TYPE 9 ANTISERUM (K961543) | Sa Scientific, Inc. | 1996-05-20 |
Recalls involving this device
No recalls on record reference this clearance.