DSL INSULIN RIA (DSL 1600)

Radioimmunoassay, Immunoreactive Insulin

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Insulin Ria (dsl 1600).

Pre-market Notification Details

Device IDK914820
510k NumberK914820
Device Name:DSL INSULIN RIA (DSL 1600)
ClassificationRadioimmunoassay, Immunoreactive Insulin
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 CodeCFP  
CFR Regulation Number862.1405 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-25
Decision Date1992-01-09

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