DSL ACTIVE IGFBP-3 IRMA (DSL 6600)

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 Active Igfbp-3 Irma (dsl 6600).

Pre-market Notification Details

Device IDK950228
510k NumberK950228
Device Name:DSL ACTIVE IGFBP-3 IRMA (DSL 6600)
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 Received1995-01-11
Decision Date1995-02-22

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