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)

CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA

K-Number: K801037 · 1980-05-28

ApplicantUnion Carbide Corp.
Decision Date1980-05-28
Product CodeLCI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA is the device name listed in this FDA 510(k) record. The listed applicant is Union Carbide Corp.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K801037. The device is classified under product code LCI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA?

CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Union Carbide Corp.. The 510(k) number is K801037.

When did CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA receive FDA 510(k) clearance?

CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA received FDA 510(k) clearance on 1980-05-28, under 510(k) number K801037.

Who is the listed applicant for CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA?

The FDA 510(k) record lists Union Carbide Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA?

The FDA product code for CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA is LCI.

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 Union Carbide Corp. 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.

K830337MARK III OXYGEN WALKER SYS-LOW PRESSK820836MARK III OXYGEN WALKER SYSTEMK820535LASER GAS MIXTURESK812536LINDE MARK IIK810732LINDE MARK II OXYGEN RESERV. TYPE OR-4K810596CENTRIFI CHEM SYSTEM 400 ANALYZER

View all 69 devices →

Related Devices (Code: LCI)

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.

K98361725-HYDROXYVITAMIN D 125I RIA KITDiaSorin, Inc.K780886SYSTEM 6000 AUTOMATED RIA ANALYZERBeckman Instruments, 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.

↑