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FDA 510(k) Application Details - K991299
Device Classification Name
Chromatographic Separation, Cpk Isoenzymes
More FDA Info for this Device
510(K) Number
K991299
Device Name
Chromatographic Separation, Cpk Isoenzymes
Applicant
PRINCETON BIOMEDITECH CORP.
4242 U.S. RT. 1
MONMOUTH JUNCTION, NJ 08852-1905 US
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Contact
JEMO KANG
Other 510(k) Applications for this Contact
Regulation Number
862.1215
More FDA Info for this Regulation Number
Classification Product Code
JHT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/06/1999
Decision Date
05/28/1999
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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