ALLERCOAT MICROPLATE SYSTEM

Colorimeter, Photometer, Spectrophotometer For Clinical Use

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 Allercoat Microplate System.

Pre-market Notification Details

Device IDK900028
510k NumberK900028
Device Name:ALLERCOAT MICROPLATE SYSTEM
ClassificationColorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactSusan Tesmer
CorrespondentSusan Tesmer
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeJJQ  
CFR Regulation Number862.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-03
Decision Date1990-01-22

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