HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE

Nadh Oxidation/nad Reduction, Alt/sgpt

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Hi-chem Diagnostics Enzyme Rinse Concentrate.

Pre-market Notification Details

Device IDK852867
510k NumberK852867
Device Name:HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE
ClassificationNadh Oxidation/nad Reduction, Alt/sgpt
Applicant HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea,  CA  92621
ContactAndrew J Estrada
CorrespondentAndrew J Estrada
HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea,  CA  92621
Product CodeCKA  
CFR Regulation Number862.1030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-08
Decision Date1985-08-29

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