CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE 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,cal-pak, Cal & Slope Standards.

Pre-market Notification Details

Device IDK020596
510k NumberK020596
Device Name:CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS
ClassificationCalibrator, Secondary
Applicant DIAMOND DIAGNOSTICS, INC. 331 FISKE ST. Holliston,  MA  01746
ContactLinda Stundtner
CorrespondentLinda 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 Received2002-02-22
Decision Date2002-03-23
Summary:summary

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