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FDA 510(k)

AMNISCREEN HOME DETECTION LINER KIT

K-Number: K071100 · 2007-10-15

ApplicantCommon Sense , Ltd.
Decision Date2007-10-15
Product CodeCEN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMNISCREEN HOME DETECTION LINER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Common Sense , Ltd.. It received FDA 510(k) clearance on 2007-10-15 under 510(k) number K071100. The device is classified under product code CEN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMNISCREEN HOME DETECTION LINER KIT?

AMNISCREEN HOME DETECTION LINER KIT is a medical device that received FDA 510(k) clearance on 2007-10-15. The listed applicant is Common Sense , Ltd.. The 510(k) number is K071100.

When did AMNISCREEN HOME DETECTION LINER KIT receive FDA 510(k) clearance?

AMNISCREEN HOME DETECTION LINER KIT received FDA 510(k) clearance on 2007-10-15, under 510(k) number K071100.

Who is the listed applicant for AMNISCREEN HOME DETECTION LINER KIT?

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

What is the FDA product code for AMNISCREEN HOME DETECTION LINER KIT?

The FDA product code for AMNISCREEN HOME DETECTION LINER KIT is CEN.

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 Common Sense , Ltd. 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.

K091287VS-SENSE TEST

Related Devices (Code: CEN)

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.

K091287VS-SENSE TESTCommon Sense , Ltd.K051727AIMSTICK URINE REAGENT STRIPSGermaine Laboratories, Inc.K040008QUICKVUE ADVANCE PH AND AMINES GLL TESTQuidel Corp.K030650STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONSUridynamics, Inc.K962718FEMEXAM TESTCARDLitmus Concepts, Inc.K840827KYOTEST 5VKyoto Diagnostics, Inc.

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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