Submission Details
| 510(k) Number | K180074 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 10, 2018 |
| Decision Date | March 22, 2018 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
Diazyme Lipoprotein (a) Assay
Mar 2018
Decision
71d
Days
Class 2
Risk
About This 510(k) Submission
K180074 is an FDA 510(k) clearance for the Diazyme Lipoprotein (a) Assay, a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II — Special Controls, product code DFC), submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on March 22, 2018, 71 days after receiving the submission on January 10, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.
Device Classification
| Product Code | DFC — Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5600 |
Manufacturer
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