FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
K Number: K955797
·
Decision Apr 5, 1996
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
32
Applicant Total
116
Review Days
105
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Basic Information
- Device Name
- IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
- K Number
- K955797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- December 22, 1995
- Decision Date
- April 5, 1996
- Product Code
- DFT
- 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 |
|---|---|---|---|
| DFT | Igm, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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