SWEET VERNAL 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 Sweet Vernal Allergen Disc.

Pre-market Notification Details

Device IDK871723
510k NumberK871723
Device Name:SWEET VERNAL ALLERGEN DISC
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
ContactJohn Yager
CorrespondentJohn 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 Received1987-05-04
Decision Date1987-07-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.