SALMONELLA FLAGELLAR A ANTIGEN & B
FDA 510(k) clearance K801693 · decided 1980-08-27
Clearance details
- K-number
- K801693
- Device name
- SALMONELLA FLAGELLAR A ANTIGEN & B
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1980-07-23
- Decision date
- 1980-08-27
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- GNC
- Device class
- 2
- Regulation number
- 866.3550
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Washington, DC, 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 |
|---|---|---|
| VISTA ANTIGEN SALMONELLA O GROUP C (K972388) | Lee Laboratories, Inc. | 1997-08-25 |
| VISTA ANTIGEN SALMONELLA O GROUP A (K972387) | Lee Laboratories, Inc. | 1997-08-25 |
| VISTA ANTIGEN SALMONELLA H B (K972391) | Lee Laboratories, Inc. | 1997-08-25 |
| VISTA ANTIGEN SALMONELLA H D (K972389) | Lee Laboratories, Inc. | 1997-08-25 |
| VISTA ANTIGEN SALMONELLA H A (K972392) | Lee Laboratories, Inc. | 1997-08-25 |
| VISTA ANTIGEN SALMONELLA H C (K972390) | Lee Laboratories, Inc. | 1997-08-25 |
| VISTA ANTIGEN SALMONELLA O GROUP B (K972386) | Lee Laboratories, Inc. | 1997-08-25 |
| VISTA ANTIGEN SALMONELLA O GROUP D (K972395) | Lee Laboratories, Inc. | 1997-08-25 |
| SAS SPICER-EDWARDS 3 ANTISERUM (K955225) | Sa Scientific, Inc. | 1996-02-13 |
| SAS SPICER-EDWARDS 2 ANTISERUM (K955224) | Sa Scientific, Inc. | 1996-02-13 |
| SAS SPICER-EDWARDS 4 ANTISERUM (K955226) | Sa Scientific, Inc. | 1996-02-13 |
| SAS SPICER-EDWARDS 1 ANTISERUM (K955223) | Sa Scientific, Inc. | 1996-02-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |