Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST

K-Number: K041202 · 2004-08-12

ApplicantW.H.P.M., Inc.
Decision Date2004-08-12
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST is the device name listed in this FDA 510(k) record. The listed applicant is W.H.P.M., Inc.. It received FDA 510(k) clearance on 2004-08-12 under 510(k) number K041202. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST?

HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST is a medical device that received FDA 510(k) clearance on 2004-08-12. The listed applicant is W.H.P.M., Inc.. The 510(k) number is K041202.

When did HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST receive FDA 510(k) clearance?

HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST received FDA 510(k) clearance on 2004-08-12, under 510(k) number K041202.

Who is the listed applicant for HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST?

The FDA 510(k) record lists W.H.P.M., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST?

The FDA product code for HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST is KHE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing W.H.P.M., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200754Hemosure Accu-Reader A100K210327First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test CupK171695First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test MarijuanaK160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)K052197FIRST SIGN DRUG OF ABUSE URINE SCREENING TESTK051841WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST

View all 10 devices →

Related Devices (Code: KHE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc.K170548InSure ONEEnterix, Inc.K171484hema-screen SPECIFIC GoldImmunostics Inc.,K162333Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd.K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestImmunostics Inc.,K121397OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KITSEKISUI Diagnostics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑