The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Active 17a-oh Progesterone Ria (dsl 5000).
Device ID | K943148 |
510k Number | K943148 |
Device Name: | DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) |
Classification | Radioimmunoassay, 17-hydroxyprogesterone |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Contact | Johnny R Willis |
Correspondent | Johnny R Willis DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Product Code | JLX |
CFR Regulation Number | 862.1395 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-30 |
Decision Date | 1994-11-10 |