SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT

Alkaline Picrate, Colorimetry, Creatinine

SIGMA DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK972743
510k NumberK972743
Device Name:SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT
ClassificationAlkaline Picrate, Colorimetry, Creatinine
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 CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-23
Decision Date1997-09-22
Summary:summary

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