FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208
K Number: K984479
·
Decision Dec 22, 1998
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
27
Applicant Total
319
Review Days
6
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Basic Information
- Device Name
- LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208
- K Number
- K984479
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad
- Date Received
- December 16, 1998
- Decision Date
- December 22, 1998
- Product Code
- LKP
- 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 |
|---|---|---|---|
| LKP | Anti-Sm Antibody, Antigen And Control | FDA class 2 | Immunology |
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