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FDA 510(k) Application Details - K992140
Device Classification Name
Atp And Creatine Kinase (Enzymatic), Creatine
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510(K) Number
K992140
Device Name
Atp And Creatine Kinase (Enzymatic), Creatine
Applicant
ABAXIS, INC.
1320 CHESAPEAKE TERRACE
SUNNYVALE, CA 94089 US
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Contact
LISA MCGRATH
Other 510(k) Applications for this Contact
Regulation Number
862.1210
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Classification Product Code
JLB
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More FDA Info for this Product Code
Date Received
06/24/1999
Decision Date
08/26/1999
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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