The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect 2nd Generation Testosterone.
| Device ID | K152155 |
| 510k Number | K152155 |
| Device Name: | ARCHITECT 2nd Generation Testosterone |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | Abbott Laboratories 100 Abbott Park Rd, Dept. 093G, Bldg. AP8-1 Abbott Park, IL 60064 |
| Contact | Regina Xavier Kumar |
| Correspondent | Regina Xavier Kumar Abbott Laboratories 100 Abbott Park Rd, Dept. 093G, Bldg. AP8-1 Abbott Park, IL 60064 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2015-12-17 |
| Summary: | summary |