FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LACTOFERRIN MICROASSAY SYSTEM
K Number: K934473
·
Decision Dec 3, 1993
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
7
Applicant Total
3
Review Days
80
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Basic Information
- Device Name
- LACTOFERRIN MICROASSAY SYSTEM
- K Number
- K934473
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5570
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Touch Scientific, Inc.
- Date Received
- September 14, 1993
- Decision Date
- December 3, 1993
- Product Code
- DEG
- 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 |
|---|---|---|---|
| DEG | Lactoferrin, Antigen, Antiserum, Control | FDA class 1 | Immunology |
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