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FDA 510(k) Application Details - K992163
Device Classification Name
Mass Spectrometer, Clinical Use
More FDA Info for this Device
510(K) Number
K992163
Device Name
Mass Spectrometer, Clinical Use
Applicant
PDZ-EUROPA LTD.
325COLLEGE RD.
CONCORD, MA 01742 US
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Contact
ROBERT F MARTIN
Other 510(k) Applications for this Contact
Regulation Number
862.2860
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Classification Product Code
DOP
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More FDA Info for this Product Code
Date Received
06/25/1999
Decision Date
07/13/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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