The following data is part of a premarket notification filed by Tosoh Bioscience, Inc. with the FDA for 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.
| Device ID | K150270 |
| 510k Number | K150270 |
| Device Name: | 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 |
| Classification | System, Test, Vitamin D |
| Applicant | TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Contact | Robert L Wick |
| Correspondent | Robert L Wick TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-04 |
| Decision Date | 2015-10-26 |
| Summary: | summary |