ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)

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 Alt Reagent Cartridge (product No. 88210).

Pre-market Notification Details

Device IDK861231
510k NumberK861231
Device Name:ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)
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 Received1986-04-01
Decision Date1986-04-28

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