FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAST TOTAL IGE
K Number: K833969
·
Decision Jan 4, 1984
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
13
Review Days
49
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Basic Information
- Device Name
- MAST TOTAL IGE
- K Number
- K833969
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Mast Immunosystems
- Date Received
- November 16, 1983
- Decision Date
- January 4, 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 Mast Immunosystems
| K Number | Device Name | ||
|---|---|---|---|
| K934524 | MAST CLA ALLERGY SYSTEM | Mar 7, 1994 | Substantially Equivalent |
| K926420 | MAST CLA ALLERGY SYSTEM | Mar 7, 1994 | Substantially Equivalent |
| K914850 | CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE | Dec 9, 1991 | Substantially Equivalent |
| K910292 | MAST CLA ALLERGY SYSTEM | Apr 5, 1991 | Substantially Equivalent |
| K870966 | TOTAL IGE MASTICK | Apr 14, 1987 | Substantially Equivalent |
| K844629 | MAST LUMINESCENT ALLERGY SYSTEM | Apr 12, 1985 | Substantially Equivalent |
| K843694 | MAST ALLERGY SYSTEM | Apr 12, 1985 | Substantially Equivalent |
| K841642 | MAST LUMINESCENT ALLERGY SYS | Jun 7, 1984 | Substantially Equivalent |
| K834526 | MAST INHALANT PROFILE | Apr 4, 1984 | Substantially Equivalent |
| K833885 | MAST INHALANT PROFILE | Jan 4, 1984 | Substantially Equivalent |