IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION

Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)

DAKO DIAGNOSTICS LTD.

The following data is part of a premarket notification filed by Dako Diagnostics Ltd. with the FDA for Ideia(tm) Chlamydia Blocking Reagents, Modification.

Pre-market Notification Details

Device IDK940564
510k NumberK940564
Device Name:IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION
ClassificationEnzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Applicant DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY Cambridgeshire,  GB Cb7 4et
ContactElisabeth A Johnson-proctor
CorrespondentElisabeth A Johnson-proctor
DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY Cambridgeshire,  GB Cb7 4et
Product CodeLJC  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-03
Decision Date1996-01-11

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