The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Active Androstanediol Glucuronide.
| Device ID | K934751 |
| 510k Number | K934751 |
| Device Name: | ACTIVE ANDROSTANEDIOL GLUCURONIDE |
| Classification | Radioimmunoassay, Androstenedione |
| 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 | CIZ |
| CFR Regulation Number | 862.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-04 |
| Decision Date | 1994-01-10 |