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)

SENSITITRE ARIS MODULE

K-Number: K911419 · 1992-07-01

ApplicantSensititre , Ltd.
Decision Date1992-07-01
Product CodeLRG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSITITRE ARIS MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Sensititre , Ltd.. It received FDA 510(k) clearance on 1992-07-01 under 510(k) number K911419. The device is classified under product code LRG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSITITRE ARIS MODULE?

SENSITITRE ARIS MODULE is a medical device that received FDA 510(k) clearance on 1992-07-01. The listed applicant is Sensititre , Ltd.. The 510(k) number is K911419.

When did SENSITITRE ARIS MODULE receive FDA 510(k) clearance?

SENSITITRE ARIS MODULE received FDA 510(k) clearance on 1992-07-01, under 510(k) number K911419.

Who is the listed applicant for SENSITITRE ARIS MODULE?

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

What is the FDA product code for SENSITITRE ARIS MODULE?

The FDA product code for SENSITITRE ARIS MODULE is LRG.

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 Sensititre , 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.

K960220SENSITITRE 18 HOUR SUSCEPTIBILITY PLATESK880641SENSITITRE STABILITY PLATES

Related Devices (Code: LRG)

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.

K191918Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher ScientificK191914Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher ScientificK110583SENSITITRE OPTIREADTrek Diagnostic Systems, Ltd.K103532AUTOREADER 2Trek Diagnostic SystemsK111677MICROSCAN(R) MICROSTREP PLUS(R)Siemens Healthcare Diagnostics, Inc.K111205MICROSCAN (R) MICROSTREP PLUS (R) PANELSSiemens Healthcare 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.

↑