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)

INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE

K-Number: K063673 · 2007-03-05

ApplicantInnovacon, Inc.
Decision Date2007-03-05
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Innovacon, Inc.. It received FDA 510(k) clearance on 2007-03-05 under 510(k) number K063673. 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 INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE?

INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE is a medical device that received FDA 510(k) clearance on 2007-03-05. The listed applicant is Innovacon, Inc.. The 510(k) number is K063673.

When did INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE receive FDA 510(k) clearance?

INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE received FDA 510(k) clearance on 2007-03-05, under 510(k) number K063673.

Who is the listed applicant for INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE?

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

What is the FDA product code for INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE?

The FDA product code for INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE 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 Innovacon, 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.

K061718INNOVACON SPECTRUM II TEST CARDK062361INNOVACON HCG UKTRA TEST DEVICE

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.

↑