FDA 510(k)
Substantially Equivalent
🇺🇸 United States
Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay
K Number: K252336
·
Decision Apr 24, 2026
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
11
Review Days
270
Basic Information
- Device Name
- Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay
- K Number
- K252336
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diazyme Laboratories, Inc.
- Date Received
- July 28, 2025
- Decision Date
- April 24, 2026
- Advisory Committee
- Unknown
- Review Advisory Committee
- IM
- Third Party
- N
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