DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440

Enzyme Linked Immunoabsorbent Assay, Rotavirus

DAKO CORP.

The following data is part of a premarket notification filed by Dako Corp. with the FDA for Dako Elisa Rotavirus Kit- 96 Tests K440.

Pre-market Notification Details

Device IDK912666
510k NumberK912666
Device Name:DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440
ClassificationEnzyme Linked Immunoabsorbent Assay, Rotavirus
Applicant DAKO CORP. P.O. BOX 1359 DK-2600 GLOSTRUP Denmark,  DK
ContactDebora D Hinman
CorrespondentDebora D Hinman
DAKO CORP. P.O. BOX 1359 DK-2600 GLOSTRUP Denmark,  DK
Product CodeLIQ  
CFR Regulation Number866.3405 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-18
Decision Date1992-02-14

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