K153375 is an FDA 510(k) clearance for the ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls. This device is classified as a System, Test, Vitamin D (Class II - Special Controls, product code MRG).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 12, 2016, 263 days after receiving the submission on November 23, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1825.
| 510(k) Number | K153375 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2015 |
| Decision Date | August 12, 2016 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MRG — System, Test, Vitamin D |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1825 |