The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Insulin Ria (dsl 1600).
Device ID | K914820 |
510k Number | K914820 |
Device Name: | DSL INSULIN RIA (DSL 1600) |
Classification | Radioimmunoassay, Immunoreactive Insulin |
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 | CFP |
CFR Regulation Number | 862.1405 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-25 |
Decision Date | 1992-01-09 |