FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAS BRUCELLA MELTIENSIS ANTIGEN
K Number: K952140
·
Decision Jul 17, 1995
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
11
Applicant Total
199
Review Days
70
Basic Information
- Device Name
- SAS BRUCELLA MELTIENSIS ANTIGEN
- K Number
- K952140
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3085
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SA SCIENTIFIC, INC.
- Date Received
- May 8, 1995
- Decision Date
- July 17, 1995
- 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 ABORTUS ANTIGEN
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by SA SCIENTIFIC, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K100227 | SAS FLUALERT A&B, SAS INFLUENZA A TEST | Feb 23, 2010 | Substantially Equivalent |
| K080380 | SAS INFLUENZA A & B TEST | Jul 23, 2009 | Substantially Equivalent |
| K041439 | SAS INFLUENZA B TEST | Jul 22, 2004 | Substantially Equivalent |
| K041441 | SAS INFLUENZA A TEST | Jul 22, 2004 | Substantially Equivalent |
| K030628 | SAS RSV CONTROL KIT | Mar 17, 2003 | Substantially Equivalent |
| K022845 | SAS RSV TEST | Jan 29, 2003 | Substantially Equivalent |
| K022683 | SAS BLOOD/SERUM/URINE/URINE HCG | Dec 16, 2002 | Substantially Equivalent |
| K023270 | SAS STREPALERT | Oct 17, 2002 | Substantially Equivalent |
| K020438 | SAS VALUE HCG | Mar 8, 2002 | Substantially Equivalent |
| K013379 | SAS STREPALERT | Dec 12, 2001 | Substantially Equivalent |