Submission Details
| 510(k) Number | K153394 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 24, 2015 |
| Decision Date | November 18, 2016 |
| Days to Decision | 360 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
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
Nov 2016
Decision
360d
Days
Class 2
Risk
About This 510(k) Submission
K153394 is an FDA 510(k) clearance for the 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, a Kappa, Antigen, Antiserum, Control (Class II — Special Controls, product code DFH), submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on November 18, 2016, 360 days after receiving the submission on November 24, 2015. 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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