QM300 CALIBRATOR G PACK

Antistreptolysin - Titer/streptolysin O Reagent

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 Qm300 Calibrator G Pack.

Pre-market Notification Details

Device IDK910885
510k NumberK910885
Device Name:QM300 CALIBRATOR G PACK
ClassificationAntistreptolysin - Titer/streptolysin O Reagent
Applicant KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactJan Nebelsick
CorrespondentJan Nebelsick
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeGTQ  
CFR Regulation Number866.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-04
Decision Date1991-06-17

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