The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Estrone (dsl 8700).
| Device ID | K935013 |
| 510k Number | K935013 |
| Device Name: | DSL ESTRONE (DSL 8700) |
| Classification | Radioimmunoassay, Estrone |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | William Taylor |
| Correspondent | William Taylor DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | CGF |
| CFR Regulation Number | 862.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-20 |
| Decision Date | 1994-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590211615 | K935013 | 000 |