IMMUNO BIOTECH MUGWART ALLERGEN DISC

System, Test, Radioallergosorbent (rast) Immunological

IMMUNO NUCLEAR CORP.

The following data is part of a premarket notification filed by Immuno Nuclear Corp. with the FDA for Immuno Biotech Mugwart Allergen Disc.

Pre-market Notification Details

Device IDK863123
510k NumberK863123
Device Name:IMMUNO BIOTECH MUGWART ALLERGEN DISC
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant IMMUNO NUCLEAR CORP. 1951 NORTHWESTERN AVE. P.O. BO 285 Stillwater,  MN  55082
ContactGreg Nelson
CorrespondentGreg Nelson
IMMUNO NUCLEAR CORP. 1951 NORTHWESTERN AVE. P.O. BO 285 Stillwater,  MN  55082
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-14
Decision Date1986-10-01

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