DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE

Colorimetric Method, Lipoproteins

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Vista Hdlc Flex Reagent Cartridge.

Pre-market Notification Details

Device IDK081300
510k NumberK081300
Device Name:DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
ClassificationColorimetric Method, Lipoproteins
Applicant SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark,  DE  19714 -6101
ContactPamela A Jurga
CorrespondentPamela A Jurga
SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark,  DE  19714 -6101
Product CodeJHM  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-08
Decision Date2008-07-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768020438 K081300 000

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