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FDA 510(k)

EZ DETECH-URINE BLOOD TEST STICKS

K-Number: K854358 · 1986-04-09

ApplicantSelf Care Systems, Inc.
Decision Date1986-04-09
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EZ DETECH-URINE BLOOD TEST STICKS is the device name listed in this FDA 510(k) record. The listed applicant is Self Care Systems, Inc.. It received FDA 510(k) clearance on 1986-04-09 under 510(k) number K854358. 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 EZ DETECH-URINE BLOOD TEST STICKS?

EZ DETECH-URINE BLOOD TEST STICKS is a medical device that received FDA 510(k) clearance on 1986-04-09. The listed applicant is Self Care Systems, Inc.. The 510(k) number is K854358.

When did EZ DETECH-URINE BLOOD TEST STICKS receive FDA 510(k) clearance?

EZ DETECH-URINE BLOOD TEST STICKS received FDA 510(k) clearance on 1986-04-09, under 510(k) number K854358.

Who is the listed applicant for EZ DETECH-URINE BLOOD TEST STICKS?

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

What is the FDA product code for EZ DETECH-URINE BLOOD TEST STICKS?

The FDA product code for EZ DETECH-URINE BLOOD TEST STICKS 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 Self Care Systems, 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.

K860923EZ DETECT, 5 MINUTE STREP-A COLOR TESTK860028MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL

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.

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