The following data is part of a premarket notification filed by Diasorin with the FDA for Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration Verifiers.
| Device ID | K130321 |
| 510k Number | K130321 |
| Device Name: | LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS |
| Classification | Radioimmunoassay, Aldosterone |
| Applicant | DIASORIN 1951 NORTHWESTERN AVENUE PO BOX 285 Stillwater, MN 55082 -0285 |
| Contact | Carol Depouw |
| Correspondent | Carol Depouw DIASORIN 1951 NORTHWESTERN AVENUE PO BOX 285 Stillwater, MN 55082 -0285 |
| Product Code | CJM |
| CFR Regulation Number | 862.1045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-08 |
| Decision Date | 2013-04-09 |
| Summary: | summary |