FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL IGE FAST TEST
K Number: K834594
·
Decision Feb 10, 1984
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
8
Review Days
43
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Basic Information
- Device Name
- TOTAL IGE FAST TEST
- K Number
- K834594
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Allergenetics
- Date Received
- December 29, 1983
- Decision Date
- February 10, 1984
- Product Code
- DGC
- 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 |
|---|---|---|---|
| DGC | Ige, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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Other Clearances by Allergenetics
| K Number | Device Name | ||
|---|---|---|---|
| K851512 | ALLERGENETICS IGE FAST TEST | May 28, 1985 | Substantially Equivalent |
| K842970 | ALLERGENTICS TOTAL IGE/THEOPHYLLINE | Aug 29, 1984 | Substantially Equivalent |
| K842969 | ALLERGENETICS ALLER-SPECIFIC IGE SERUM | Aug 28, 1984 | Substantially Equivalent |
| K833418 | CHYMOFAST TEST | Mar 12, 1984 | Substantially Equivalent |
| K833419 | LABELED 125I ANTI-IGE | Feb 3, 1984 | Substantially Equivalent |
| K834244 | THEOFAST TEST KIT FOR QUANTITATIVE THEO | Jan 24, 1984 | Substantially Equivalent |
| K822341 | ALLERGENETICS IGE-FAST TEST | Nov 10, 1982 | Substantially Equivalent |