FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WELLCOLEX COLOUR SALMONELLA TEST ZL 50
K Number: K890146
·
Decision Feb 16, 1989
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
68
Applicant Total
28
Review Days
34
Basic Information
- Device Name
- WELLCOLEX COLOUR SALMONELLA TEST ZL 50
- K Number
- K890146
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3550
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- WELLCOME DIAGNOSTICS
- Date Received
- January 13, 1989
- Decision Date
- February 16, 1989
- 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
Other Clearances by WELLCOME DIAGNOSTICS
| K Number | Device Name | ||
|---|---|---|---|
| K915203 | D-DIMER WELLCOTEST (HA10) | Jan 31, 1992 | Substantially Equivalent |
| K910797 | STREPTEX ACID EXTRACTION KIT | Mar 29, 1991 | Substantially Equivalent |
| K895461 | WELLCOLEX COLOUR SHIGELLA TEST ZC51 | Jan 11, 1990 | Substantially Equivalent |
| K875311 | WELLCOZYME HSV WZO2 | Aug 3, 1988 | Substantially Equivalent |
| K861628 | WELLCOZYME ROTAVIRUS WZ01 | Jan 21, 1987 | Substantially Equivalent |
| K864206 | REVEAL COLOUR STREP A ZL16 | Jan 13, 1987 | Substantially Equivalent |
| K861634 | THE WELLCOME ROTAVIRUS LATEX TEST ZL40 | Oct 29, 1986 | Substantially Equivalent |
| K854852 | WELLCOGEN BACTERIAL ANTIGEN KIT | Feb 4, 1986 | Substantially Equivalent |
| K854851 | WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 | Feb 4, 1986 | Substantially Equivalent |
| K851691 | WILLCOGEN MENINGITIDIS KIT ZL25 | Jun 10, 1985 | Substantially Equivalent |