The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Estradial Radioimmunoassay (dsl-4400).
| Device ID | K870405 |
| 510k Number | K870405 |
| Device Name: | DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400) |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | Gopal Savjami |
| Correspondent | Gopal Savjami DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-03 |
| Decision Date | 1987-06-08 |