FDA 510(k)
FDA class 2
Substantially Equivalent
🇲🇽 Mexico
BRUCELLA IFA*
K Number: K885112
·
Decision Aug 15, 1989
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
11
Applicant Total
24
Review Days
246
Basic Information
- Device Name
- BRUCELLA IFA*
- K Number
- K885112
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3085
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- INVESTIGACION FARMACEUTICA S.A. DE C.V.
- Date Received
- December 12, 1988
- Decision Date
- August 15, 1989
- Product Code
- GSO
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GSO | Antigens (Febrile), Agglutination, Brucella Spp. | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GSO), ordered by most recent decision date.
VISTA ANTIGEN BRUCELLA MELITENSIS
FDA 510(k)
FDA Class 2
·Microbiology
VISTA ANTIGEN BRUCELLA ABORTUS
FDA 510(k)
FDA Class 2
·Microbiology
SAS BRUCELLA SUIS ANTIGEN
FDA 510(k)
FDA Class 2
·Microbiology
SAS SALMONELLA H A ANTIGEN
FDA 510(k)
FDA Class 2
·Microbiology
SAS FEBRILE ANTIGEN SET
FDA 510(k)
FDA Class 2
·Microbiology
SAS BRUCELLA MELTIENSIS ANTIGEN
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by INVESTIGACION FARMACEUTICA S.A. DE C.V.
| K Number | Device Name | ||
|---|---|---|---|
| K892721 | IFA SENSIBAC CEFACLOR | Nov 30, 1989 | Substantially Equivalent |
| K892728 | IFA SENSIBAC NORFLOXACIN | Sep 21, 1989 | Substantially Equivalent |
| K892713 | IFA SENSIBAC NALIDIXIC ACID | Aug 17, 1989 | Substantially Equivalent |
| K892733 | IFA SENSIBAC KANAMYCIN | Aug 17, 1989 | Substantially Equivalent |
| K892735 | IFA SENSIBAC CEPHALOTIN | Aug 17, 1989 | Substantially Equivalent |
| K892720 | IFA SENSIBAC GENTAMYCIN | Aug 15, 1989 | Substantially Equivalent |
| K885110 | PROTEUS OX-19 IFA* | Aug 15, 1989 | Substantially Equivalent |
| K885114 | SALMONELLA IFA* | Aug 15, 1989 | Substantially Equivalent |
| K885113 | IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL | Aug 15, 1989 | Substantially Equivalent |
| K892726 | IFA SENSIBAC PENICILLIN | Aug 15, 1989 | Substantially Equivalent |