Hemosure Accu-Reader A100

Automated Occult Blood Analyzer

W.H.P.M., Inc

The following data is part of a premarket notification filed by W.h.p.m., Inc with the FDA for Hemosure Accu-reader A100.

Pre-market Notification Details

Device IDK200754
510k NumberK200754
Device Name:Hemosure Accu-Reader A100
ClassificationAutomated Occult Blood Analyzer
Applicant W.H.P.M., Inc 5358 North Irwindale Avenue Irwindale,  CA  91706
ContactFarokh Etemedieh
CorrespondentFarokh Etemadieh
Smith Associates 5358 North Irwindale Avenue Irwindale,  CA  91706
Product CodeOOX  
CFR Regulation Number864.6550 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-23
Decision Date2022-06-02

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