The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Free Testosterone Enzyme Immunoassay, Model Dsl-10-4900.
| Device ID | K001086 |
| 510k Number | K001086 |
| Device Name: | FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | John Class |
| Correspondent | John Class DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-04 |
| Decision Date | 2000-05-18 |