CLEANING REAGENT KIT PRODUCT NO 88194

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Cleaning Reagent Kit Product No 88194.

Pre-market Notification Details

Device IDK855196
510k NumberK855196
Device Name:CLEANING REAGENT KIT PRODUCT NO 88194
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant HI CHEM, INC. P.O. BOX 1599 Brea,  CA  92622
ContactAndrew Estrada
CorrespondentAndrew Estrada
HI CHEM, INC. P.O. BOX 1599 Brea,  CA  92622
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-26
Decision Date1986-01-22

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