QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE

Enzyme Immunoassay, Barbiturate

GENERAL DIAGNOSTICS

The following data is part of a premarket notification filed by General Diagnostics with the FDA for Quali. Enzyme Immuno. Of Barbiturates In Urine.

Pre-market Notification Details

Device IDK864993
510k NumberK864993
Device Name:QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE
ClassificationEnzyme Immunoassay, Barbiturate
Applicant GENERAL DIAGNOSTICS 160 COMMUNITY DR. Great Neck,  NY  11021
ContactSusan M Durham
CorrespondentSusan M Durham
GENERAL DIAGNOSTICS 160 COMMUNITY DR. Great Neck,  NY  11021
Product CodeDIS  
CFR Regulation Number862.3150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-22
Decision Date1987-03-31

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