QUANTIMETRIC PLUS C4 REAGENT KIT

Complement C4, 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 C4 Reagent Kit.

Pre-market Notification Details

Device IDK855012
510k NumberK855012
Device Name:QUANTIMETRIC PLUS C4 REAGENT KIT
ClassificationComplement C4, 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 CodeDBI  
CFR Regulation Number866.5240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-16
Decision Date1986-02-26

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