ENDAB PHENOBARBITAL

Enzyme Immunoassay, Phenobarbital

IMMUNOTECH CORP.

The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab Phenobarbital.

Pre-market Notification Details

Device IDK852995
510k NumberK852995
Device Name:ENDAB PHENOBARBITAL
ClassificationEnzyme Immunoassay, Phenobarbital
Applicant IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston,  MA  02134
ContactJohn H Carter
CorrespondentJohn H Carter
IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston,  MA  02134
Product CodeDLZ  
CFR Regulation Number862.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-15
Decision Date1985-08-12

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