PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT

Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)

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 Pathfinder(tm) Chlamydia Microplate Kit.

Pre-market Notification Details

Device IDK902253
510k NumberK902253
Device Name:PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT
ClassificationEnzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Applicant KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactCheri W Fink
CorrespondentCheri W Fink
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeLJC  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-21
Decision Date1990-07-26

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