RUSSIAN THISTLE 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 Russian Thistle Allergen Disc.

Pre-market Notification Details

Device IDK862176
510k NumberK862176
Device Name:RUSSIAN THISTLE ALLERGEN DISC
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant IMMUNO NUCLEAR CORP. 1951 NORTHWESTERN AVE. P.O. BO 285 Stillwater,  MN  55082
ContactLisa J Andersen
CorrespondentLisa J Andersen
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 Received1986-06-09
Decision Date1986-08-15

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