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)

ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400

K-Number: K043067 · 2005-05-31

ApplicantBioarray Solutions, Ltd.
Decision Date2005-05-31
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 is the device name listed in this FDA 510(k) record. The listed applicant is Bioarray Solutions, Ltd.. It received FDA 510(k) clearance on 2005-05-31 under 510(k) number K043067. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400?

ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 is a medical device that received FDA 510(k) clearance on 2005-05-31. The listed applicant is Bioarray Solutions, Ltd.. The 510(k) number is K043067.

When did ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 receive FDA 510(k) clearance?

ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 received FDA 510(k) clearance on 2005-05-31, under 510(k) number K043067.

Who is the listed applicant for ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400?

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

What is the FDA product code for ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400?

The FDA product code for ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 is LLL.

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

Related Devices (Code: LLL)

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.

K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems LimitedK253367EliA CTD 13 ScreenPhadia ABK250666Alegria Flash CTD ScreenZeus ScientificK250408Alegria Flash ENA ScreenZeus ScientificK213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.K190710EliA SymphonyS ImmunoassayPhadia AB

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.

↑