The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Ultra-sensitive Estradiol.
| Device ID | K953605 |
| 510k Number | K953605 |
| Device Name: | ULTRA-SENSITIVE ESTRADIOL |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | John Willis |
| Correspondent | John 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 | 1995-08-02 |
| Decision Date | 1995-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590211523 | K953605 | 000 |