The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Direct Renin Liaison Control Direct Renin Liaison Endocrinology Diluent.
| Device ID | K121944 |
| 510k Number | K121944 |
| Device Name: | LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT |
| Classification | Radioimmunoassay, Angiotensin I And Renin |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Contact | Mari Meyer |
| Correspondent | Mari Meyer DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Product Code | CIB |
| CFR Regulation Number | 862.1085 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-03 |
| Decision Date | 2013-01-01 |