DSL 9100 IGF-II IRMA

Radioimmunoassay, Human Growth 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 9100 Igf-ii Irma.

Pre-market Notification Details

Device IDK962758
510k NumberK962758
Device Name:DSL 9100 IGF-II IRMA
ClassificationRadioimmunoassay, Human Growth Hormone
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 CodeCFL  
CFR Regulation Number862.1370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-16
Decision Date1996-08-30
Summary:summary

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