DSL ANDROSTENEDIONE RIA (DSL # 4200)

Radioimmunoassay, Androstenedione

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Androstenedione Ria (dsl # 4200).

Pre-market Notification Details

Device IDK854673
510k NumberK854673
Device Name:DSL ANDROSTENEDIONE RIA (DSL # 4200)
ClassificationRadioimmunoassay, Androstenedione
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 CodeCIZ  
CFR Regulation Number862.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-11-21
Decision Date1986-01-22

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