FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAS SALMONELLA H Z4, Z23 ANTISERUM
K Number: K955187
·
Decision Feb 2, 1996
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
59
Applicant Total
199
Review Days
80
Basic Information
- Device Name
- SAS SALMONELLA H Z4, Z23 ANTISERUM
- K Number
- K955187
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3550
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SA SCIENTIFIC, INC.
- Date Received
- November 14, 1995
- Decision Date
- February 2, 1996
- Product Code
- GNC
- 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 |
|---|---|---|---|
| GNC | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GNC), ordered by most recent decision date.
VISTA ANTIGEN SALMONELLA H A
FDA 510(k)
FDA Class 2
·Microbiology
VISTA ANTIGEN SALMONELLA O GROUP A
FDA 510(k)
FDA Class 2
·Microbiology
VISTA ANTIGEN SALMONELLA O GROUP D
FDA 510(k)
FDA Class 2
·Microbiology
VISTA ANTIGEN SALMONELLA O GROUP B
FDA 510(k)
FDA Class 2
·Microbiology
VISTA ANTIGEN SALMONELLA H D
FDA 510(k)
FDA Class 2
·Microbiology
VISTA ANTIGEN SALMONELLA H C
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 |