CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)

Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)

INTERCARE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Intercare Diagnostics, Inc. with the FDA for Chlamydia Tissue Culture Confirmation Test (eia).

Pre-market Notification Details

Device IDK862948
510k NumberK862948
Device Name:CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)
ClassificationEnzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Applicant INTERCARE DIAGNOSTICS, INC. 1440 4TH ST. Berkeley,  CA  94710
ContactStan Tsing
CorrespondentStan Tsing
INTERCARE DIAGNOSTICS, INC. 1440 4TH ST. Berkeley,  CA  94710
Product CodeLJC  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-05
Decision Date1986-10-17

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