DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS

Calibrator, Secondary

DIAMOND DIAGNOSTICS, INC

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

Pre-market Notification Details

Device IDK133751
510k NumberK133751
Device Name:DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
ClassificationCalibrator, Secondary
Applicant DIAMOND DIAGNOSTICS, INC 333 Fiske St Holliston,  MA  01746
ContactKathy Cruz
CorrespondentKathy Cruz
DIAMOND DIAGNOSTICS, INC 333 Fiske St Holliston,  MA  01746
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-09
Decision Date2014-08-08
Summary:summary

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