VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007

Multi-analyte Controls, All Kinds (assayed)

MAINE STANDARDS CO.

The following data is part of a premarket notification filed by Maine Standards Co. with the FDA for Validate Chem 7 Calibration Verification Test Set, Model 10007.

Pre-market Notification Details

Device IDK013265
510k NumberK013265
Device Name:VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant MAINE STANDARDS CO. 765 ROOSEVELT TRAIL Windham,  ME  04062 -5365
ContactChristine Beach
CorrespondentChristine Beach
MAINE STANDARDS CO. 765 ROOSEVELT TRAIL Windham,  ME  04062 -5365
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-01
Decision Date2001-11-20
Summary:summary

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