Submission Details
| 510(k) Number | K220001 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 04, 2022 |
| Decision Date | August 04, 2022 |
| Days to Decision | 212 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
Aug 2022
Decision
212d
Days
Class 2
Risk
About This 510(k) Submission
K220001 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 August 4, 2022, 212 days after receiving the submission on January 4, 2022. 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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