Submission Details
| 510(k) Number | K181438 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 01, 2018 |
| Decision Date | June 26, 2018 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Special
Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay
Jun 2018
Decision
25d
Days
Class 2
Risk
About This 510(k) Submission
K181438 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 June 26, 2018, 25 days after receiving the submission on June 1, 2018. 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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