FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN
K Number: K840867
·
Decision May 11, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
29
Review Days
74
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Basic Information
- Device Name
- ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN
- K Number
- K840867
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5130
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Intl. Diagnostic Technology
- Date Received
- February 27, 1984
- Decision Date
- May 11, 1984
- Product Code
- DEI
- 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 |
|---|---|---|---|
| DEI | Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DEI), ordered by most recent decision date.
View allOther Clearances by Intl. Diagnostic Technology
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K834140 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS | Jan 20, 1984 | Substantially Equivalent |
| K833984 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL | Jan 4, 1984 | Substantially Equivalent |
| K832821 | FIAX IGG TEST | Oct 14, 1983 | Substantially Equivalent |