FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WELLCOGEN H. INFLUENZAL ZL21
K Number: K833077
·
Decision Jan 10, 1984
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
28
Review Days
123
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Basic Information
- Device Name
- WELLCOGEN H. INFLUENZAL ZL21
- K Number
- K833077
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3380
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Wellcome Diagnostics
- Date Received
- September 9, 1983
- Decision Date
- January 10, 1984
- Product Code
- GRD
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| GRD | Antiserum, Hai, Mumps Virus | FDA class 1 | 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 |
| K890146 | WELLCOLEX COLOUR SALMONELLA TEST ZL 50 | Feb 16, 1989 | 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 |