FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONO-PLUS(TM)
K Number: K883004
·
Decision Aug 4, 1988
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
58
Applicant Total
12
Review Days
17
Basic Information
- Device Name
- MONO-PLUS(TM)
- K Number
- K883004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- WAMPOLE LABORATORIES
- Date Received
- July 18, 1988
- Decision Date
- August 4, 1988
- 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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