The following data is part of a premarket notification filed by Radioassay Systems Laboratories, Inc. with the FDA for Rsl (125i) Aldosterone Kit.
| Device ID | K862204 |
| 510k Number | K862204 |
| Device Name: | RSL (125I) ALDOSTERONE KIT |
| Classification | Radioimmunoassay, Aldosterone |
| Applicant | RADIOASSAY SYSTEMS LABORATORIES, INC. 2015 UNIVERSITY DR. Carson, CA 90746 |
| Contact | Burns, Ph.d |
| Correspondent | Burns, Ph.d RADIOASSAY SYSTEMS LABORATORIES, INC. 2015 UNIVERSITY DR. Carson, CA 90746 |
| Product Code | CJM |
| CFR Regulation Number | 862.1045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-10 |
| Decision Date | 1986-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817830022269 | K862204 | 000 |