DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)

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 1900 Active Human Growth Hormone Irma (dsl 1900).

Pre-market Notification Details

Device IDK970701
510k NumberK970701
Device Name:DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)
ClassificationRadioimmunoassay, Human Growth Hormone
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactJonh Willis
CorrespondentJonh 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 Received1997-02-26
Decision Date1997-04-02
Summary:summary

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