The following data is part of a premarket notification filed by Cis Bio International with the FDA for Cisbio Renin Ria Test.
| Device ID | K062120 |
| 510k Number | K062120 |
| Device Name: | CISBIO RENIN RIA TEST |
| Classification | Radioimmunoassay, Angiotensin I And Renin |
| Applicant | CIS BIO INTERNATIONAL 150 CHERRY LANE ROAD East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus CIS BIO INTERNATIONAL 150 CHERRY LANE ROAD East Stroudsburg, PA 18301 |
| Product Code | CIB |
| CFR Regulation Number | 862.1085 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-25 |
| Decision Date | 2007-03-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661541510518 | K062120 | 000 |
| 03770024321319 | K062120 | 000 |