MULTI-ANALYTE CHEMISTRY CALIBRATOR

Calibrator, Multi-analyte Mixture

POINTE SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Multi-analyte Chemistry Calibrator.

Pre-market Notification Details

Device IDK070207
510k NumberK070207
Device Name:MULTI-ANALYTE CHEMISTRY CALIBRATOR
ClassificationCalibrator, Multi-analyte Mixture
Applicant POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton,  MI  48188
ContactRon Jamison
CorrespondentRon Jamison
POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton,  MI  48188
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-22
Decision Date2007-04-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00811727013972 K070207 000
00811727010704 K070207 000
00850053916267 K070207 000

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