LIPOPRINT SYSTEM, LDL SUBFRACTIONS

Electrophoretic Separation, Lipoproteins

QUANTIMETRIX CORP.

The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Lipoprint System, Ldl Subfractions.

Pre-market Notification Details

Device IDK010337
510k NumberK010337
Device Name:LIPOPRINT SYSTEM, LDL SUBFRACTIONS
ClassificationElectrophoretic Separation, Lipoproteins
Applicant QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach,  CA  90278 -1205
ContactGebhard Neyer
CorrespondentGebhard Neyer
QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. Redondo Beach,  CA  90278 -1205
Product CodeJHO  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-05
Decision Date2001-07-25

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