Submission Details
| 510(k) Number | K172992 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 2017 |
| Decision Date | January 11, 2018 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
Diazyme EZ Vitamin D Assay
Jan 2018
Decision
106d
Days
Class 2
Risk
About This 510(k) Submission
K172992 is an FDA 510(k) clearance for the Diazyme EZ Vitamin D Assay, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on January 11, 2018, 106 days after receiving the submission on September 27, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.
Device Classification
| Product Code | MRG — System, Test, Vitamin D |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1825 |
Manufacturer
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