DSL ACTIVE PROLACTIN ELISA MODEL 10-4500

Radioimmunoassay, Prolactin (lactogen)

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 Prolactin Elisa Model 10-4500.

Pre-market Notification Details

Device IDK960561
510k NumberK960561
Device Name:DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
ClassificationRadioimmunoassay, Prolactin (lactogen)
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 CodeCFT  
CFR Regulation Number862.1625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-09
Decision Date1996-04-26

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