The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Androstenedione Ria (dsl # 4200).
Device ID | K854673 |
510k Number | K854673 |
Device Name: | DSL ANDROSTENEDIONE RIA (DSL # 4200) |
Classification | Radioimmunoassay, Androstenedione |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Contact | Gopal Savjani |
Correspondent | Gopal Savjani 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 | 1985-11-21 |
Decision Date | 1986-01-22 |