QUANTIMETRIC PLUS SUPPORT PACK

Lambda, Antigen, Antiserum, Control

KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantimetric Plus Support Pack.

Pre-market Notification Details

Device IDK855013
510k NumberK855013
Device Name:QUANTIMETRIC PLUS SUPPORT PACK
ClassificationLambda, Antigen, Antiserum, Control
Applicant KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactQuinlan Smith
CorrespondentQuinlan Smith
KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeDEH  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-16
Decision Date1986-02-26

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