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FDA 510(k) Application Details - K984277
Device Classification Name
Enzyme Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K984277
Device Name
Enzyme Controls (Assayed And Unassayed)
Applicant
MEDICAL ANALYSIS SYSTEMS, INC.
542 FLYNN RD.
CAMARILLO, CA 93012-8058 US
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Contact
SCOT D KINGHORN
Other 510(k) Applications for this Contact
Regulation Number
862.1660
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Classification Product Code
JJT
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More FDA Info for this Product Code
Date Received
11/30/1998
Decision Date
12/09/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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