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FDA 510(k) Application Details - K955770
Device Classification Name
Kinetic Method, Gamma-Glutamyl Transpeptidase
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510(K) Number
K955770
Device Name
Kinetic Method, Gamma-Glutamyl Transpeptidase
Applicant
ABAXIS, INC.
1320 CHESAPEAKE TERRACE
SUNNYVALE, CA 94089 US
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Contact
DANIEL WONG
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Regulation Number
862.1360
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Classification Product Code
JQB
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Date Received
12/21/1995
Decision Date
09/09/1996
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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