The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison 25 Oh Vitamin D Total Calibration Verifiers, Model: 310603.
| Device ID | K090104 |
| 510k Number | K090104 |
| Device Name: | LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Contact | Kelly R Sauer |
| Correspondent | Kelly R Sauer DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-15 |
| Decision Date | 2009-09-09 |
| Summary: | summary |