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FDA 510(k) Application Details - K955444
Device Classification Name
Enzyme Immunoassay, Procainamide
More FDA Info for this Device
510(K) Number
K955444
Device Name
Enzyme Immunoassay, Procainamide
Applicant
ABBOTT LABORATORIES
DEPT: 09V8 BLDG: AP5-2
100 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064-3500 US
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Contact
GRACE LEMIEUX
Other 510(k) Applications for this Contact
Regulation Number
862.3320
More FDA Info for this Regulation Number
Classification Product Code
LAR
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More FDA Info for this Product Code
Date Received
11/28/1995
Decision Date
04/02/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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