Cleared Traditional

Hemosure Accu-Reader A100

K200754 · W.H.P.M., Inc. · Hematology
Jun 2022
Decision
801d
Days
Class 2
Risk

About This 510(k) Submission

K200754 is an FDA 510(k) clearance for the Hemosure Accu-Reader A100, a Automated Occult Blood Analyzer (Class II — Special Controls, product code OOX), submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on June 2, 2022, 801 days after receiving the submission on March 23, 2020. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K200754 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2020
Decision Date June 02, 2022
Days to Decision 801 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code OOX — Automated Occult Blood Analyzer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6550
Definition The Automated Test System Is Intended For The Qualitative Detection Of Fecal Occult Blood In Feces By Professional Laboratories. The Automated Test Is Used For The Determination Of Gastrointestinal Bleeding.

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