GOLDENROD ALLERGEN DISC

System, Test, Radioallergosorbent (rast) Immunological

INCSTAR CORP.

The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Goldenrod Allergen Disc.

Pre-market Notification Details

Device IDK875163
510k NumberK875163
Device Name:GOLDENROD ALLERGEN DISC
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
ContactJohn G Yager
CorrespondentJohn G Yager
INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-16
Decision Date1988-04-21

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