MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT

Enzyme Immunoassay, Amphetamine

IMMUNOTECH CORP.

The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Microzyme(tm) Methamphet/amphet Enzyme Immuno Kit.

Pre-market Notification Details

Device IDK903993
510k NumberK903993
Device Name:MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT
ClassificationEnzyme Immunoassay, Amphetamine
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 CodeDKZ  
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-29
Decision Date1990-12-20

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