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FDA 510(k)

AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM

K-Number: K971103 · 1997-06-27

ApplicantTosoh Medics, Inc.
Decision Date1997-06-27
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Medics, Inc.. It received FDA 510(k) clearance on 1997-06-27 under 510(k) number K971103. 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 NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM?

AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-27. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K971103.

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

AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM received FDA 510(k) clearance on 1997-06-27, under 510(k) number K971103.

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

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

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

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

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Other records listing Tosoh Medics, Inc. as applicant

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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 IncorporatedK962919VITROS IMMUNODIAGNOSTIC SYSTEMJohnson & Johnson Clinical Diagnostics, Inc.K952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)Biocircuits Corp.K950415FLUOROSCAN NEONATALIsolab, Inc.K935047AUTO DELFIAWallac OY

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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