FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036
K Number: K853144
·
Decision Oct 16, 1985
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
58
Applicant Total
4
Review Days
79
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Basic Information
- Device Name
- CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036
- K Number
- K853144
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Preco, Inc.
- Date Received
- July 29, 1985
- Decision Date
- October 16, 1985
- Product Code
- KTN
- 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 |
|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | FDA class 2 | Immunology |
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