IMMUNOTECH CHOLESTEROL TEST

Enzymatic Esterase--oxidase, Cholesterol

IMMUNOTECH CORP.

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

Pre-market Notification Details

Device IDK897036
510k NumberK897036
Device Name:IMMUNOTECH CHOLESTEROL TEST
ClassificationEnzymatic Esterase--oxidase, Cholesterol
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 CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-18
Decision Date1990-03-06

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