ACTIVE T3 RIA

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 Active T3 Ria.

Pre-market Notification Details

Device IDK960550
510k NumberK960550
Device Name:ACTIVE T3 RIA
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 Received1996-02-08
Decision Date1996-03-06
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.