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FDA 510(k) Application Details - K962975
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K962975
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES, CA 90045-5597 US
Other 510(k) Applications for this Company
Contact
EDWARD M LEVINE, PH.D.
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
07/31/1996
Decision Date
08/29/1996
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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