TRIGLYCERIDE CALIBRATOR

Calibrator, Secondary

HARLECO DIAGNOSTICS

The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Triglyceride Calibrator.

Pre-market Notification Details

Device IDK822852
510k NumberK822852
Device Name:TRIGLYCERIDE CALIBRATOR
ClassificationCalibrator, Secondary
Applicant HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-09-24
Decision Date1982-10-27

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