SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936

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 Diagnostics Sigma-cal, Model S2936.

Pre-market Notification Details

Device IDK010652
510k NumberK010652
Device Name:SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
ClassificationCalibrator, Multi-analyte Mixture
Applicant SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis,  MO  63103
ContactWilliam R Gilbert Ii
CorrespondentWilliam R Gilbert Ii
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 Received2001-03-05
Decision Date2001-03-30

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