SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1

Calibrator, Multi-analyte Mixture

SIGMA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Diagnostic Cx -3 Calibration Standard Level 1.

Pre-market Notification Details

Device IDK963533
510k NumberK963533
Device Name:SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1
ClassificationCalibrator, Multi-analyte Mixture
Applicant SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis,  MO  63103
ContactWilliam R Gilbert
CorrespondentWilliam R Gilbert
SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis,  MO  63103
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-04
Decision Date1996-10-29
Summary:summary

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