PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED

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 Eia Detect Kit/modified.

Pre-market Notification Details

Device IDK884517
510k NumberK884517
Device Name:PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
ClassificationEnzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Applicant KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactQuinlan Smith
CorrespondentQuinlan Smith
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 Received1988-10-27
Decision Date1988-11-30

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