FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
D-DIMER WELLCOTEST (HA10)
K Number: K915203
·
Decision Jan 31, 1992
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
56
Applicant Total
28
Review Days
74
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Basic Information
- Device Name
- D-DIMER WELLCOTEST (HA10)
- K Number
- K915203
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wellcome Diagnostics
- Date Received
- November 18, 1991
- Decision Date
- January 31, 1992
- Product Code
- DAP
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | FDA class 2 | Hematology |
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Other Clearances by Wellcome Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K851691 | WILLCOGEN MENINGITIDIS KIT ZL25 | Jun 10, 1985 | Substantially Equivalent |