Submission Details
| 510(k) Number | K162298 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 2016 |
| Decision Date | March 16, 2017 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
Mar 2017
Decision
212d
Days
Class 2
Risk
About This 510(k) Submission
K162298 is an FDA 510(k) clearance for the LOCI Total Vitamin D Total Assay, LOCI VITD CAL, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on March 16, 2017, 212 days after receiving the submission on August 16, 2016. 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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