ACTIVE IGF-I ELISA

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 Active Igf-i Elisa.

Pre-market Notification Details

Device IDK951752
510k NumberK951752
Device Name:ACTIVE IGF-I ELISA
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 Received1995-04-17
Decision Date1995-05-10

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