DSL ACTIVE T3 EIA

Radioimmunoassay, Total Triiodothyronine

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 T3 Eia.

Pre-market Notification Details

Device IDK971270
510k NumberK971270
Device Name:DSL ACTIVE T3 EIA
ClassificationRadioimmunoassay, Total Triiodothyronine
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 CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-04
Decision Date1997-05-22
Summary:summary

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