FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
K Number: K211648
·
Decision Sep 8, 2022
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
11
Review Days
468
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Basic Information
- Device Name
- Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
- K Number
- K211648
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diazyme Laboratories, Inc.
- Date Received
- May 28, 2021
- Decision Date
- September 8, 2022
- 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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Other Clearances by Diazyme Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253069 | Lipoprotein (a) Molarity Assay | Jun 16, 2026 | Substantially Equivalent |
| K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay | Apr 24, 2026 | Substantially Equivalent |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | Dec 19, 2025 | Substantially Equivalent |
| K243462 | Diazyme Colorimetric Lithium Assay | Aug 1, 2025 | Substantially Equivalent |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | Aug 4, 2022 | Substantially Equivalent |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer | Dec 13, 2021 | Substantially Equivalent |
| K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity | Aug 6, 2021 | Substantially Equivalent |
| K180209 | Diazyme 1,5-AG Assay | Oct 4, 2018 | Substantially Equivalent |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay | Jun 26, 2018 | Substantially Equivalent |
| K180074 | Diazyme Lipoprotein (a) Assay | Mar 22, 2018 | Substantially Equivalent |