Cleared Traditional

HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST

K041202 · W.H.P.M., Inc. · Hematology
Aug 2004
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K041202 is an FDA 510(k) clearance for the HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by W.H.P.M., Inc. (Beverly, US). The FDA issued a Cleared decision on August 12, 2004, 97 days after receiving the submission on May 7, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K041202 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2004
Decision Date August 12, 2004
Days to Decision 97 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KHE — Reagent, Occult Blood
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6550

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