PLATELIA RUBELLA IGG KIT

Enzyme Linked Immunoabsorbent Assay, Rubella

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 Platelia Rubella Igg Kit.

Pre-market Notification Details

Device IDK894946
510k NumberK894946
Device Name:PLATELIA RUBELLA IGG KIT
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubella
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 CodeLFX  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-03
Decision Date1989-12-21

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