DART PHENOBARBITAL ASSAY SYSTEM

Nephelometric Inhibition Immunoassay, Phenobarbital

COULTER ELECTRONICS, INC.

The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Dart Phenobarbital Assay System.

Pre-market Notification Details

Device IDK864612
510k NumberK864612
Device Name:DART PHENOBARBITAL ASSAY SYSTEM
ClassificationNephelometric Inhibition Immunoassay, Phenobarbital
Applicant COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah,  FL  33010
ContactRichardson-jones
CorrespondentRichardson-jones
COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah,  FL  33010
Product CodeLFN  
CFR Regulation Number862.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-24
Decision Date1987-01-13

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