DSL ACTIVE I-HCG IRMA

Visual, Pregnancy Hcg, Prescription Use

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 I-hcg Irma.

Pre-market Notification Details

Device IDK960357
510k NumberK960357
Device Name:DSL ACTIVE I-HCG IRMA
ClassificationVisual, Pregnancy Hcg, Prescription Use
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 CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-25
Decision Date1996-05-07
Summary:summary

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