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FDA 510(k) Application Details - K965114
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
More FDA Info for this Device
510(K) Number
K965114
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES, CA 90045-5597 US
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Contact
EDWARD M LEVINE
Other 510(k) Applications for this Contact
Regulation Number
862.1660
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Classification Product Code
JJY
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More FDA Info for this Product Code
Date Received
12/20/1996
Decision Date
02/20/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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