The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Active Ultra-sensitive Unconjugated Estriol.
| Device ID | K955356 |
| 510k Number | K955356 |
| Device Name: | ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL |
| Classification | Radioimmunoassay, Estriol |
| 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 | CGI |
| CFR Regulation Number | 862.1265 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-21 |
| Decision Date | 1996-05-15 |
| Summary: | summary |