DSL ACTIVE T4 EIA

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Active T4 Eia.

Pre-market Notification Details

Device IDK971269
510k NumberK971269
Device Name:DSL ACTIVE T4 EIA
ClassificationEnzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactJohn Willis
CorrespondentJohn Willis
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
Product CodeKLI  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-04
Decision Date1997-05-22
Summary:summary

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