MODIFIED PATHFINDER SPECIMEN COLLECTION KIT

Device, Specimen Collection

KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.

The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Modified Pathfinder Specimen Collection Kit.

Pre-market Notification Details

Device IDK870963
510k NumberK870963
Device Name:MODIFIED PATHFINDER SPECIMEN COLLECTION KIT
ClassificationDevice, Specimen Collection
Applicant KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactQuinlan Smith
CorrespondentQuinlan Smith
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeLIO  
CFR Regulation Number866.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-10
Decision Date1987-04-08

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