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FDA 510(k) Application Details - K984107
Device Classification Name
System, Test, Low Density, Lipoprotein
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510(K) Number
K984107
Device Name
System, Test, Low Density, Lipoprotein
Applicant
REFERENCE DIAGNOSTICS, INC.
23 CROSBY DR.
BEDFORD, MA 01730 US
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Contact
JOSEPH LAWLOR
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Regulation Number
862.1475
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Classification Product Code
MRR
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More FDA Info for this Product Code
Date Received
11/17/1998
Decision Date
01/28/1999
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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