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FDA 510(k) Application Details - K081875
Device Classification Name
Test, Cystatin C
More FDA Info for this Device
510(K) Number
K081875
Device Name
Test, Cystatin C
Applicant
GENTIAN AS
9915 CAM. CHIRIMOLLA
SAN DIEGO, CA 92131 US
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Contact
ERIC S GRUFF
Other 510(k) Applications for this Contact
Regulation Number
862.1225
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Classification Product Code
NDY
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More FDA Info for this Product Code
Date Received
07/02/2008
Decision Date
08/20/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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