VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006

Single (specified) Analyte Controls (assayed And Unassayed)

MAINE STANDARDS CO.

The following data is part of a premarket notification filed by Maine Standards Co. with the FDA for Validate Chem 6 Calibration Verification Test Set Model # 10006.

Pre-market Notification Details

Device IDK013119
510k NumberK013119
Device Name:VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
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 CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-09-18
Decision Date2001-11-16
Summary:summary

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