FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLIPSCREEN (TM) TOTAL E IMMUNOASSAY
K Number: K885307
·
Decision Mar 8, 1989
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
113
Applicant Total
3
Review Days
71
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Basic Information
- Device Name
- FLIPSCREEN (TM) TOTAL E IMMUNOASSAY
- K Number
- K885307
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Alerchek, Inc.
- Date Received
- December 27, 1988
- Decision Date
- March 8, 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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