DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

Kit, Test,alpha-fetoprotein For Testicular Cancer

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 Afp Elisa, Model Dsl-10-8400.

Pre-market Notification Details

Device IDK990138
510k NumberK990138
Device Name:DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
ClassificationKit, Test,alpha-fetoprotein For Testicular Cancer
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactJohn Class
CorrespondentJohn Class
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
Product CodeLOJ  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-19
Decision Date1999-06-21
Summary:summary

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