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FDA 510(k) Application Details - K955468
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K955468
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
BEHRING DIAGNOSTICS, INC.
151 UNIVERSITY AVE.
WESTWOOD, MA 02090 US
Other 510(k) Applications for this Company
Contact
NANCY M JOHANSEN
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
11/30/1995
Decision Date
02/23/1996
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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