DSL-4800 ACTIVE TM TSH EIA SYSTEM

Radioimmunoassay, Thyroid-stimulating Hormone

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl-4800 Active Tm Tsh Eia System.

Pre-market Notification Details

Device IDK864134
510k NumberK864134
Device Name:DSL-4800 ACTIVE TM TSH EIA SYSTEM
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactGopal Savjani
CorrespondentGopal Savjani
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-21
Decision Date1986-12-16

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