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FDA 510(k) Application Details - K961432
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K961432
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
BIO-RAD
4000 ALFRED NOBEL DR.
HERCULES, CA 94547-1803 US
Other 510(k) Applications for this Company
Contact
TREVOR WALL
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/15/1996
Decision Date
10/28/1996
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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