CHLAMYDIA SYSTEM SOFTWARE (CSS)

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 Chlamydia System Software (css).

Pre-market Notification Details

Device IDK904725
510k NumberK904725
Device Name:CHLAMYDIA SYSTEM SOFTWARE (CSS)
ClassificationEnzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
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 CodeLJC  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-17
Decision Date1991-01-14

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