MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT

Enzyme Immunoassay, Phencyclidine

IMMUNOTECH CORP.

The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Microzyme Phencyclidine Enzyme Immunoassay Test Kt.

Pre-market Notification Details

Device IDK911153
510k NumberK911153
Device Name:MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT
ClassificationEnzyme Immunoassay, Phencyclidine
Applicant IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston,  MA  02134
ContactFrancis E Capitanio
CorrespondentFrancis E Capitanio
IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston,  MA  02134
Product CodeLCM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-15
Decision Date1991-06-18

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