DSL SOMATOMEDIN-C (DSL #5600)

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 Somatomedin-c (dsl #5600).

Pre-market Notification Details

Device IDK875229
510k NumberK875229
Device Name:DSL SOMATOMEDIN-C (DSL #5600)
ClassificationRadioimmunoassay, Human Growth Hormone
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactJohnny Willis
CorrespondentJohnny 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 Received1987-12-22
Decision Date1988-07-01

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