The following data is part of a premarket notification filed by Radioassay Systems Laboratories, Inc. with the FDA for (125i) Testosterone Kit.
| Device ID | K791999 |
| 510k Number | K791999 |
| Device Name: | (125I) TESTOSTERONE KIT |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | RADIOASSAY SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-05 |
| Decision Date | 1979-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817830023204 | K791999 | 000 |
| 00817830023211 | K791999 | 000 |