VISTA ANTIGEN BRUCELLA ABORTUS
FDA 510(k) clearance K972394 · decided 1997-08-25
Clearance details
- K-number
- K972394
- Device name
- VISTA ANTIGEN BRUCELLA ABORTUS
- 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
- GSO
- Device class
- 2
- Regulation number
- 866.3085
- 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 BRUCELLA MELITENSIS (K972396) | Lee Laboratories, Inc. | 1997-08-25 |
| SAS BRUCELLA SUIS ANTIGEN (K952139) | Sa Scientific, Inc. | 1995-07-18 |
| SAS SALMONELLA H A ANTIGEN (K952137) | Sa Scientific, Inc. | 1995-07-17 |
| SAS FEBRILE ANTIGEN SET (K952131) | Sa Scientific, Inc. | 1995-07-17 |
| SAS BRUCELLA MELTIENSIS ANTIGEN (K952140) | Sa Scientific, Inc. | 1995-07-17 |
| SAS BRUCELLA ABORTUS ANTIGEN (K952147) | Sa Scientific, Inc. | 1995-07-17 |
| SAS SALMONELLA H B ANTIGEN (K952136) | Sa Scientific, Inc. | 1995-07-17 |
| SAS SALMONELLA H D ANTIGEN (K952135) | Sa Scientific, Inc. | 1995-07-17 |
| BRUCELLA IFA* (K885112) | Investigacion Farmaceutica S.A. DE C.V. | 1989-08-15 |
| FEBRILE ANTIGEN KIT (K822663) | Oxoid U.S.A., Inc. | 1982-09-21 |
| AGGLUTINOTEST-BRUCELLA (K791449) | Volu Sol Medical Industries | 1979-09-24 |
Recalls involving this device
No recalls on record reference this clearance.