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)

AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM

K-Number: K923021 · 1992-07-21

ApplicantTosoh Corp.
Decision Date1992-07-21
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Corp.. It received FDA 510(k) clearance on 1992-07-21 under 510(k) number K923021. The device is classified under product code KHO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM?

AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1992-07-21. The listed applicant is Tosoh Corp.. The 510(k) number is K923021.

When did AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM receive FDA 510(k) clearance?

AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM received FDA 510(k) clearance on 1992-07-21, under 510(k) number K923021.

Who is the listed applicant for AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM?

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

What is the FDA product code for AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM?

The FDA product code for AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM is KHO.

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 Tosoh 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.

K023240ST AIA-PACK CA 19-9K023239AIA-PACK CA 19-9K913663AIA-PACK T-UK913298AIA-PACK CK-MBK913493AIA-PACK FT4K903628AIA-PACK IRI

View all 11 devices →

Related Devices (Code: KHO)

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.

K112161AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..Radiometer Medical ApsK973547TRIAGE STATMETERBiosite IncorporatedK971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Medics, Inc.K962919VITROS IMMUNODIAGNOSTIC SYSTEMJohnson & Johnson Clinical Diagnostics, Inc.K952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)Biocircuits Corp.K950415FLUOROSCAN NEONATALIsolab, 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.

↑