FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALLERG-E IGE ENZYME IMMUNOASSAY KIT
K Number: K853607
·
Decision Nov 7, 1985
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
14
Applicant Total
4
Review Days
71
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Basic Information
- Device Name
- ALLERG-E IGE ENZYME IMMUNOASSAY KIT
- K Number
- K853607
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Dexall Biomedical Labs, Inc.
- Date Received
- August 28, 1985
- Decision Date
- November 7, 1985
- Product Code
- DGO
- 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 |
|---|---|---|---|
| DGO | Ige, Peroxidase, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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