The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Testosterone Test System; Calibrator; And Quality Control Material (assayed And Unassayed).
| Device ID | K120009 |
| 510k Number | K120009 |
| Device Name: | TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK ROAD DEPT 9V6, AP5N-2 Abbott Park, IL 60064 |
| Contact | John Rizos |
| Correspondent | John Rizos ABBOTT LABORATORIES 100 ABBOTT PARK ROAD DEPT 9V6, AP5N-2 Abbott Park, IL 60064 |
| Product Code | CDZ |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-03 |
| Decision Date | 2012-09-11 |
| Summary: | summary |