ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100

Enzyme Immunoassay, Inhibin-a

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Active Inhibin-a Elisa, Model Dsl-10-28100.

Pre-market Notification Details

Device IDK002128
510k NumberK002128
Device Name:ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
ClassificationEnzyme Immunoassay, Inhibin-a
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactMichael (rusty) Nicar
CorrespondentMichael (rusty) Nicar
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
Product CodeNDR  
CFR Regulation Number862.1260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-14
Decision Date2000-12-05

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