Submission Details
| 510(k) Number | K211648 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 28, 2021 |
| Decision Date | September 08, 2022 |
| Days to Decision | 468 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
Sep 2022
Decision
468d
Days
Class 2
Risk
About This 510(k) Submission
K211648 is an FDA 510(k) clearance for the Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, a Kappa, Antigen, Antiserum, Control (Class II — Special Controls, product code DFH), submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on September 8, 2022, 468 days after receiving the submission on May 28, 2021. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.
Device Classification
| Product Code | DFH — Kappa, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5550 |
Manufacturer
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