SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL

Control, Plasma, Abnormal

SIGMA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Diagnostics Accuclot La Control.

Pre-market Notification Details

Device IDK020109
510k NumberK020109
Device Name:SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
ClassificationControl, Plasma, Abnormal
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 CodeGGC  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-11
Decision Date2002-02-06
Summary:summary

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