HOUSE DUST; HOLLISTER-STIER (H/S) 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 House Dust; Hollister-stier (h/s) Allergen Disc.

Pre-market Notification Details

Device IDK875110
510k NumberK875110
Device Name:HOUSE DUST; HOLLISTER-STIER (H/S) 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 Received1987-12-14
Decision Date1988-06-14

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