510(k) K822663
- Device
- FEBRILE ANTIGEN KIT
- Applicant
- OXOID U.S.A., INC.
- 510(k) number
- K822663
- Product code
- GSO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-09-21
- Date received
- 1982-09-03
- Regulation
- 866.3085
- Classification name
- Antigens (febrile), Agglutination, Brucella Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3003750284
- 1649661
- 3005360469
- 3024463179
- 2250030
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GSO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972394 | VISTA ANTIGEN BRUCELLA ABORTUS | Lee Laboratories, Inc. | 1997-08-25 |
| K972396 | VISTA ANTIGEN BRUCELLA MELITENSIS | Lee Laboratories, Inc. | 1997-08-25 |
| K952139 | SAS BRUCELLA SUIS ANTIGEN | Sa Scientific, Inc. | 1995-07-18 |
| K952131 | SAS FEBRILE ANTIGEN SET | Sa Scientific, Inc. | 1995-07-17 |
| K952135 | SAS SALMONELLA H D ANTIGEN | Sa Scientific, Inc. | 1995-07-17 |
| K952136 | SAS SALMONELLA H B ANTIGEN | Sa Scientific, Inc. | 1995-07-17 |
| K952137 | SAS SALMONELLA H A ANTIGEN | Sa Scientific, Inc. | 1995-07-17 |
| K952140 | SAS BRUCELLA MELTIENSIS ANTIGEN | Sa Scientific, Inc. | 1995-07-17 |
| K952147 | SAS BRUCELLA ABORTUS ANTIGEN | Sa Scientific, Inc. | 1995-07-17 |
| K885112 | BRUCELLA IFA* | Investigacion Farmaceutica S.A. DE C.V. | 1989-08-15 |
| K791449 | AGGLUTINOTEST-BRUCELLA | Volu Sol Medical Industries | 1979-09-24 |
Legacy Summary#
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FDA Review#
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