EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

Cyclosporine

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Emit 2000 Cyclosporine Specific Assay.

Pre-market Notification Details

Device IDK053061
510k NumberK053061
Device Name:EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
ClassificationCyclosporine
Applicant DADE BEHRING, INC. P.O. BOX 6101 M/S 514 Newark,  DE  19714 -6101
ContactYuk-ting Lewis
CorrespondentYuk-ting Lewis
DADE BEHRING, INC. P.O. BOX 6101 M/S 514 Newark,  DE  19714 -6101
Product CodeMKW  
CFR Regulation Number862.1235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-31
Decision Date2006-02-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768001451 K053061 000

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