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FDA 510(k) Application Details - K062092
Device Classification Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
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510(K) Number
K062092
Device Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Applicant
PREMD, INC.
16809 BRIARDALE ROAD
ROCKVILLE, MD 20855 US
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Contact
THOMAS M TSAKERIS
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Regulation Number
862.1475
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Classification Product Code
LBS
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Date Received
07/24/2006
Decision Date
09/15/2006
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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