The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Active Estradiol Ria (dsl #4300).
| Device ID | K873550 |
| 510k Number | K873550 |
| Device Name: | DSL ACTIVE ESTRADIOL RIA (DSL #4300) |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | Johnny Willis |
| Correspondent | Johnny Willis 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 | 1987-08-31 |
| Decision Date | 1988-02-18 |