SMS GLUCOSE CONTROL, MODEL 2120061

Single (specified) Analyte Controls (assayed And Unassayed)

SPECTRUM MEDICAL SUPPLY, INC.

The following data is part of a premarket notification filed by Spectrum Medical Supply, Inc. with the FDA for Sms Glucose Control, Model 2120061.

Pre-market Notification Details

Device IDK070649
510k NumberK070649
Device Name:SMS GLUCOSE CONTROL, MODEL 2120061
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant SPECTRUM MEDICAL SUPPLY, INC. 940 CROSSROADS BLVD Seguin,  TX  78155
ContactJohn C Gormley
CorrespondentJohn C Gormley
SPECTRUM MEDICAL SUPPLY, INC. 940 CROSSROADS BLVD Seguin,  TX  78155
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-08
Decision Date2007-04-12
Summary:summary

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