INCSTAR'S PIGWEED 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 Incstar's Pigweed Allergen Disc.

Pre-market Notification Details

Device IDK880221
510k NumberK880221
Device Name:INCSTAR'S PIGWEED 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 Received1988-01-20
Decision Date1988-05-11

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