FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIA-PACK IGE II ASSAY
K Number: K972697
·
Decision Oct 3, 1997
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
41
Review Days
77
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Basic Information
- Device Name
- AIA-PACK IGE II ASSAY
- K Number
- K972697
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tosoh Medics, Inc.
- Date Received
- July 18, 1997
- Decision Date
- October 3, 1997
- 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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|---|---|---|---|
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