FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SALMONELLA O GROUPING ANTISERA SET
K Number: K912791
·
Decision Oct 5, 1992
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
68
Applicant Total
1
Review Days
468
Basic Information
- Device Name
- SALMONELLA O GROUPING ANTISERA SET
- K Number
- K912791
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3550
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- S.M.I. MEDICAL, INC.
- Date Received
- June 25, 1991
- Decision Date
- October 5, 1992
- Product Code
- GRM
- 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 |
|---|---|---|---|
| GRM | Antisera, All Groups, Salmonella Spp. | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GRM), ordered by most recent decision date.
SAS SALMONELLA O FACTOR 20 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
SAS SALMONELLA H Z35 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
SAS SALMONELLA O FACTOR 6 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
SAS SALMONELLA H F,G,T ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
SAS SALMONELLA H Z4 COMPLEX ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology