FDA.reportPublic FDA data

510(k) K200754

Device
Hemosure Accu-Reader A100
Applicant
W.H.P.M., Inc
510(k) number
K200754
Product code
OOX  
Decision
Substantially Equivalent (SESE)
Decision date
2022-06-02
Date received
2020-03-23
Regulation
864.6550
Classification name
Automated Occult Blood Analyzer
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Farokh Etemedieh
Address
5358 N. Irwindale Ave. Irwindale CA US 91706 91706

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OOX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191147OC-Auto SENSOR io iFOB TestEiken Chemical Co., Ltd.2020-01-02
K163225AFIAS iFOB with AFIAS-50Immunostics Inc.,2017-08-08
K132167I-CHROMA IFOB WITH I-CHROMA READERBoditech Med, Inc.2014-05-02
K092330OC-SENSOR DIANA IFOB TESTPolymedco Cancer Diagnostics, LLC2010-01-08
K041408POLYMEDCO OC AUTO MICRO 80 FOB TESTPolymedco, Inc.2004-10-21

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases