The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl C-peptide Ria (dsl #7000).
Device ID | K896420 |
510k Number | K896420 |
Device Name: | DSL C-PEPTIDE RIA (DSL #7000) |
Classification | Radioimmunoassay, C-peptides Of Proinsulin |
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 | JKD |
CFR Regulation Number | 862.1135 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-08 |
Decision Date | 1990-05-24 |