CALIBRATING MATERIAL, CAL-PAK, BUFFERS

Calibrator, Secondary

MISSION DIAGNOSTICS

The following data is part of a premarket notification filed by Mission Diagnostics with the FDA for Calibrating Material, Cal-pak, Buffers.

Pre-market Notification Details

Device IDK020894
510k NumberK020894
Device Name:CALIBRATING MATERIAL, CAL-PAK, BUFFERS
ClassificationCalibrator, Secondary
Applicant MISSION DIAGNOSTICS 331 FISKE ST. Holliston,  MA  01746
ContactLinda Stundtner
CorrespondentLinda Stundtner
MISSION DIAGNOSTICS 331 FISKE ST. Holliston,  MA  01746
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-19
Decision Date2002-04-29
Summary:summary

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