IDEIA(TM) ROTAVIRUS

Enzyme Linked Immunoabsorbent Assay, Rotavirus

DAKO DIAGNOSTICS LTD.

The following data is part of a premarket notification filed by Dako Diagnostics Ltd. with the FDA for Ideia(tm) Rotavirus.

Pre-market Notification Details

Device IDK932384
510k NumberK932384
Device Name:IDEIA(TM) ROTAVIRUS
ClassificationEnzyme Linked Immunoabsorbent Assay, Rotavirus
Applicant DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY Cambridgeshire,  GB Cb7 4et
ContactJohnson-proctor
CorrespondentJohnson-proctor
DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY Cambridgeshire,  GB Cb7 4et
Product CodeLIQ  
CFR Regulation Number866.3405 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-17
Decision Date1993-12-27

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