THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS

Calibrators, Drug Mixture

MICROGENICS CORP.

The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Thermo Scientific Cedia Multi-drug Oft Calibrators.

Pre-market Notification Details

Device IDK101752
510k NumberK101752
Device Name:THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
ClassificationCalibrators, Drug Mixture
Applicant MICROGENICS CORP. 46360 FREMONT BLVD Fremont,  CA  94538
ContactLisa Charter
CorrespondentLisa Charter
MICROGENICS CORP. 46360 FREMONT BLVD Fremont,  CA  94538
Product CodeDKB  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-22
Decision Date2011-04-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883011045 K101752 000
00884883011038 K101752 000
00884883010987 K101752 000

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