WASH SOLUTION KIT, #88102

Analyzer, Chemistry, Micro, For Clinical Use

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Wash Solution Kit, #88102.

Pre-market Notification Details

Device IDK802264
510k NumberK802264
Device Name:WASH SOLUTION KIT, #88102
ClassificationAnalyzer, Chemistry, Micro, For Clinical Use
Applicant HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJF  
CFR Regulation Number862.2170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-09-16
Decision Date1980-10-31

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