FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REVEAL COLOUR STREP A ZL16
K Number: K864206
·
Decision Jan 13, 1987
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
28
Review Days
78
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Basic Information
- Device Name
- REVEAL COLOUR STREP A ZL16
- K Number
- K864206
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Wellcome Diagnostics
- Date Received
- October 27, 1986
- Decision Date
- January 13, 1987
- Product Code
- GTZ
- 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 |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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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 |
| 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 |