CALIBRATING MATERIAL, CALIBRATING STANDARDS

Calibrator, Secondary

DIAMOND DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Diamond Diagnostics, Inc. with the FDA for Calibrating Material, Calibrating Standards.

Pre-market Notification Details

Device IDK031159
510k NumberK031159
Device Name:CALIBRATING MATERIAL, CALIBRATING STANDARDS
ClassificationCalibrator, Secondary
Applicant DIAMOND DIAGNOSTICS, INC. 331 FISKE ST. Holliston,  MA  01746
ContactLinda M Stundtner
CorrespondentLinda M Stundtner
DIAMOND DIAGNOSTICS, INC. 331 FISKE ST. Holliston,  MA  01746
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-14
Decision Date2003-06-25
Summary:summary

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