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FDA 510(k) Application Details - K161526
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K161526
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
DiaSorin Inc.
1951 Northwestern Avenue
Stillwater, MN 555082 US
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Contact
JOHN WALTER
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/02/2016
Decision Date
06/30/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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