FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RF CARD TEST
K Number: K853054
·
Decision Aug 1, 1985
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
143
Applicant Total
4
Review Days
13
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Basic Information
- Device Name
- RF CARD TEST
- K Number
- K853054
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Preco, Inc.
- Date Received
- July 19, 1985
- Decision Date
- August 1, 1985
- Product Code
- DHR
- 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 |
|---|---|---|---|
| DHR | System, Test, Rheumatoid Factor | FDA class 2 | Immunology |
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