VISTA ANTIGEN SALMONELLA H D
FDA 510(k) clearance K972389 · decided 1997-08-25
Clearance details
- K-number
- K972389
- Device name
- VISTA ANTIGEN SALMONELLA H D
- Applicant
- Lee Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-26
- Decision date
- 1997-08-25
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- GNC
- Device class
- 2
- Regulation number
- 866.3550
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Grayson, GA, 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 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 |
| SAS SPICER-EDWARDS L COMPLEX (K955228) | Sa Scientific, Inc. | 1996-02-13 |
Recalls involving this device
No recalls on record reference this clearance.