The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Progesterone Ria (dsl #3400).
Device ID | K854649 |
510k Number | K854649 |
Device Name: | DSL PROGESTERONE RIA (DSL #3400) |
Classification | Radioimmunoassay, Progesterone |
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 | JLS |
CFR Regulation Number | 862.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-19 |
Decision Date | 1985-12-13 |