FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROGENE IGE BEAD EIA
K Number: K895294
·
Decision Sep 21, 1989
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
3
Review Days
27
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Basic Information
- Device Name
- PROGENE IGE BEAD EIA
- K Number
- K895294
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Progene Corp.
- Date Received
- August 25, 1989
- Decision Date
- September 21, 1989
- 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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