FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LABELED 125I ANTI-IGE
K Number: K833419
·
Decision Feb 3, 1984
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
8
Review Days
123
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LABELED 125I ANTI-IGE
- K Number
- K833419
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Allergenetics
- Date Received
- October 3, 1983
- Decision Date
- February 3, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DGC), ordered by most recent decision date.
Kenota 1 Total IgE; Kenota 1 (instrument)
FDA 510(k)
FDA Class 2
·Immunology
Quantia IgE
FDA 510(k)
FDA Class 2
·Immunology
Total Immunoglobulin E (IgE)
FDA 510(k)
FDA Class 2
·Immunology
ADVIA Centaur Total IgE (tIgE)
FDA 510(k)
FDA Class 2
·Immunology
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
FDA 510(k)
FDA Class 2
·Immunology
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
FDA 510(k)
FDA Class 2
·Immunology
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 |
| K834594 | TOTAL IGE FAST TEST | Feb 10, 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 |