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FDA 510(k) Application Details - K981278
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K981278
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
ROCHE DIAGNOSTICS GMBH
4300 HACIENDA DR.
PLEASANTON, CA 94566-0900 US
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Contact
Patricia M Klimley
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJX
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More FDA Info for this Product Code
Date Received
04/08/1998
Decision Date
04/23/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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