ALKALINE BUFFER

Alkaline Picrate, Colorimetry, Creatinine

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Alkaline Buffer.

Pre-market Notification Details

Device IDK791688
510k NumberK791688
Device Name:ALKALINE BUFFER
ClassificationAlkaline Picrate, Colorimetry, Creatinine
Applicant HI CHEM, INC. 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 Received1979-07-31
Decision Date1979-09-17

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