The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Renak.
| Device ID | K831694 |
| 510k Number | K831694 |
| Device Name: | RENAK |
| Classification | Radioimmunoassay, Angiotensin I And Renin |
| Applicant | HOFFMANN-LA ROCHE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIB |
| CFR Regulation Number | 862.1085 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-24 |
| Decision Date | 1983-07-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RENAK 74653124 2098557 Dead/Cancelled |
Reichenbacher Naben und Fahrrad-Komponenten GmbH 1995-03-22 |
![]() RENAK 73152038 1106408 Dead/Cancelled |
HOFFMANN-LA ROCHE INC. 1977-12-14 |
![]() RENAK 73152037 1099120 Dead/Cancelled |
1977-12-14 |