HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193

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 Hi Chem Diagnostics Cleaning Neutralizer Sol#88193.

Pre-market Notification Details

Device IDK853003
510k NumberK853003
Device Name:HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant HI CHEM, INC. P.O. BOX 1599 Brea,  CA  92622
ContactAndrew J Estrada
CorrespondentAndrew J 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 Received1985-07-16
Decision Date1985-08-06

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