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FDA 510(k)

AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM

K-Number: K901674 · 1990-05-02

ApplicantTosoh Corp.
Decision Date1990-05-02
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIA-600 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 1990-05-02 under 510(k) number K901674. 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-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM?

AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1990-05-02. The listed applicant is Tosoh Corp.. The 510(k) number is K901674.

When did AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM receive FDA 510(k) clearance?

AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM received FDA 510(k) clearance on 1990-05-02, under 510(k) number K901674.

Who is the listed applicant for AIA-600 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-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM?

The FDA product code for AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM is KHO.

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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.

K023239AIA-PACK CA 19-9K023240ST AIA-PACK CA 19-9K923021AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEMK913663AIA-PACK T-UK913298AIA-PACK CK-MBK913493AIA-PACK FT4

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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.

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