FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator
K Number: K153394
·
Decision Nov 18, 2016
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
41
Review Days
360
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Basic Information
- Device Name
- Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator
- K Number
- K153394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diazyme Laboratories
- Date Received
- November 24, 2015
- Decision Date
- November 18, 2016
- Product Code
- DFH
- 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 |
|---|---|---|---|
| DFH | Kappa, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
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Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
FDA 510(k)
FDA Class 2
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