AP REAGENT CARTRIDGE

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

HI CHEM, INC.

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

Pre-market Notification Details

Device IDK861284
510k NumberK861284
Device Name:AP REAGENT CARTRIDGE
ClassificationNitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
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 CodeCJE  
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-07
Decision Date1986-04-28

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