The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison N-tact Pth Calibration Verifiers Model 310913.
| Device ID | K093498 |
| 510k Number | K093498 |
| Device Name: | LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
| Contact | Carol A Depouw |
| Correspondent | Carol A Depouw DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-12 |
| Decision Date | 2009-12-14 |
| Summary: | summary |