The following data is part of a premarket notification filed by Serono Laboratories, Inc. with the FDA for Aldosterone Radioimmunoassay Test Kit.
| Device ID | K834428 |
| 510k Number | K834428 |
| Device Name: | ALDOSTERONE RADIOIMMUNOASSAY TEST KIT |
| Classification | Radioimmunoassay, Aldosterone |
| Applicant | SERONO LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CJM |
| CFR Regulation Number | 862.1045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-15 |
| Decision Date | 1984-03-02 |