ULTRACHEM T-BILI

Diazo Colorimetry, Bilirubin

HARLECO DIAGNOSTICS

The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Ultrachem T-bili.

Pre-market Notification Details

Device IDK821873
510k NumberK821873
Device Name:ULTRACHEM T-BILI
ClassificationDiazo Colorimetry, Bilirubin
Applicant HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-25
Decision Date1982-07-14

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