SALMONELLA I.D.
FDA 510(k) clearance K821338 · decided 1982-05-28
Clearance details
- K-number
- K821338
- Device name
- SALMONELLA I.D.
- Applicant
- Analytical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-05
- Decision date
- 1982-05-28
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- GRM
- Device class
- 2
- Regulation number
- 866.3550
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Walker, MI, 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S010) | Analytical Products, Inc. | 1984-05-04 |
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S009) | Analytical Products, Inc. | 1984-04-24 |
| UNISCEPT(TM) (P830028/S001) | Analytical Products, Inc. | 1984-03-09 |
| UNISCEPT(TM) (P830028) | Analytical Products, Inc. | 1984-03-01 |
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S007) | Analytical Products, Inc. | 1983-11-25 |
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S008) | Analytical Products, Inc. | 1983-11-17 |
| OMNISCEPT(TM) KB SYSTEM (P800029/S005) | Analytical Products, Inc. | 1983-07-05 |
| API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S003) | Analytical Products, Inc. | 1982-06-18 |