DETERMINATION OF PHENOBARBITAL

Enzyme Immunoassay, Phenobarbital

CLINICAL DATA, INC.

The following data is part of a premarket notification filed by Clinical Data, Inc. with the FDA for Determination Of Phenobarbital.

Pre-market Notification Details

Device IDK860046
510k NumberK860046
Device Name:DETERMINATION OF PHENOBARBITAL
ClassificationEnzyme Immunoassay, Phenobarbital
Applicant CLINICAL DATA, INC. 1172 COMMONWEALTH AVE. Boston,  MA  02134
ContactIsrael M Stein,m.d.
CorrespondentIsrael M Stein,m.d.
CLINICAL DATA, INC. 1172 COMMONWEALTH AVE. Boston,  MA  02134
Product CodeDLZ  
CFR Regulation Number862.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-06
Decision Date1986-01-22

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