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FDA 510(k) Application Details - K990184
Device Classification Name
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510(K) Number
K990184
Device Name
AUTOMARQER
Applicant
HAMILTON THORNE RESEARCH
100 CUMMINGS CENTER
SUITE 102-C
BEVERLY, MA 01915 US
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Contact
DIARMAID DOUGLAS-HAMILTON
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Regulation Number
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Classification Product Code
POV
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Date Received
01/20/1999
Decision Date
03/19/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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