FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
OXOID INFECTIOUS MONONUCLEOSIS KIT
K Number: K883540
·
Decision Oct 19, 1988
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
58
Applicant Total
73
Review Days
62
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Basic Information
- Device Name
- OXOID INFECTIOUS MONONUCLEOSIS KIT
- K Number
- K883540
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Unipath , Ltd.
- Date Received
- August 18, 1988
- Decision Date
- October 19, 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 |
Similar 510(k) Clearances
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| K032939 | EPT CERTAINTY PREGNANCY TEST | Oct 20, 2003 | Substantially Equivalent |