K150270 is an FDA 510(k) clearance for the ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set. This device is classified as a System, Test, Vitamin D (Class II - Special Controls, product code MRG).
Submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on October 26, 2015, 264 days after receiving the submission on February 4, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1825.
| 510(k) Number | K150270 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2015 |
| Decision Date | October 26, 2015 |
| Days to Decision | 264 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 |