DSL C-PEPTIDE RIA (DSL #7000)

Radioimmunoassay, C-peptides Of Proinsulin

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

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).

Pre-market Notification Details

Device IDK896420
510k NumberK896420
Device Name:DSL C-PEPTIDE RIA (DSL #7000)
ClassificationRadioimmunoassay, C-peptides Of Proinsulin
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactJohnny R Willis
CorrespondentJohnny R Willis
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
Product CodeJKD  
CFR Regulation Number862.1135 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-08
Decision Date1990-05-24

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