SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

SIGMA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Diagnostics Auto D-dimer Calibrator, Model A7971.

Pre-market Notification Details

Device IDK013549
510k NumberK013549
Device Name:SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
ClassificationFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
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 CodeDAP  
CFR Regulation Number864.7320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-24
Decision Date2001-12-26
Summary:summary

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