The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Loci Total Vitamin D Total Assay, Loci Vitd Cal.
| Device ID | K162298 |
| 510k Number | K162298 |
| Device Name: | LOCI Total Vitamin D Total Assay, LOCI VITD CAL |
| Classification | System, Test, Vitamin D |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE P.O. BOX 6101 Newark, DE 19714 |
| Contact | Kathleen Dray-lyons |
| Correspondent | Kathleen Dray-lyons SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE P.O. BOX 6101 Newark, DE 19714 |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-16 |
| Decision Date | 2017-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768037740 | K162298 | 000 |