URIC ACID STANDARD, 8MG/DL #65078

Calibrator, Primary

HARLECO DIAGNOSTICS

The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Uric Acid Standard, 8mg/dl #65078.

Pre-market Notification Details

Device IDK823147
510k NumberK823147
Device Name:URIC ACID STANDARD, 8MG/DL #65078
ClassificationCalibrator, Primary
Applicant HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJIS  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-25
Decision Date1982-11-22

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