ULTRACHEM CREA

Alkaline Picrate, Colorimetry, Creatinine

HARLECO DIAGNOSTICS

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

Pre-market Notification Details

Device IDK821881
510k NumberK821881
Device Name:ULTRACHEM CREA
ClassificationAlkaline Picrate, Colorimetry, Creatinine
Applicant HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-25
Decision Date1982-07-14

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