FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIAX CRP TEST KIT
K Number: K832054
·
Decision Aug 26, 1983
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
125
Applicant Total
29
Review Days
60
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Basic Information
- Device Name
- FIAX CRP TEST KIT
- K Number
- K832054
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Intl. Diagnostic Technology
- Date Received
- June 27, 1983
- Decision Date
- August 26, 1983
- Product Code
- DCK
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | FDA class 2 | Immunology |
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Other Clearances by Intl. Diagnostic Technology
| K Number | Device Name | ||
|---|---|---|---|
| K850591 | FIAX TOXO-M ANTIBODIES TEST KIT | Apr 30, 1985 | Substantially Equivalent |
| K843570 | FIAX HAPTOGLOBIN TEST KIT | Oct 5, 1984 | Substantially Equivalent |
| K843621 | FIAX 420 DILUTOR | Sep 28, 1984 | Substantially Equivalent |
| K843356 | FIAX 100 FLUOROMETER | Sep 17, 1984 | Substantially Equivalent |
| K842749 | FIAX TOTAL IGE TEST KIT | Aug 28, 1984 | Substantially Equivalent |
| K842071 | FIAX TRANSFERRIN TEST KIT | Jul 11, 1984 | Substantially Equivalent |
| K841174 | RUBELLA ANTIBODY FLUOROIMMUNOASSAY | Jun 7, 1984 | Substantially Equivalent |
| K840867 | ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN | May 11, 1984 | Substantially Equivalent |
| K834140 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS | Jan 20, 1984 | Substantially Equivalent |
| K833984 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL | Jan 4, 1984 | Substantially Equivalent |