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 Ai.
| Device ID | K123131 |
| 510k Number | K123131 |
| 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 AI |
| 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 |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-04 |
| Decision Date | 2013-02-08 |
| Summary: | summary |