FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIACROM * FACTOR X KIT HA31
K Number: K832372
·
Decision Sep 29, 1983
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
28
Review Days
73
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Basic Information
- Device Name
- DIACROM * FACTOR X KIT HA31
- K Number
- K832372
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Wellcome Diagnostics
- Date Received
- July 18, 1983
- Decision Date
- September 29, 1983
- Product Code
- GGP
- Advisory Committee
- Hematology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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| K875311 | WELLCOZYME HSV WZO2 | Aug 3, 1988 | Substantially Equivalent |
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| 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 |
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