QM2/QM300 CONTROL A PACK

Multi-analyte Controls, All Kinds (assayed)

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 Qm2/qm300 Control A Pack.

Pre-market Notification Details

Device IDK871342
510k NumberK871342
Device Name:QM2/QM300 CONTROL A PACK
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactJan Petersen
CorrespondentJan Petersen
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-02
Decision Date1987-05-21

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