IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST

System, Test, Radioallergosorbent (rast) Immunological

INCSTAR CORP.

The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Ige Immuno Response Test (irt) Comp. For Mod. Rast.

Pre-market Notification Details

Device IDK873814
510k NumberK873814
Device Name:IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
ContactLisa J Stone
CorrespondentLisa J Stone
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 Received1987-09-21
Decision Date1987-10-20

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