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FDA 510(k)

TECHNISON AXON SYSTEM

K-Number: K941156 · 1994-04-26

ApplicantMiles, Inc.
Decision Date1994-04-26
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECHNISON AXON SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Miles, Inc.. It received FDA 510(k) clearance on 1994-04-26 under 510(k) number K941156. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNISON AXON SYSTEM?

TECHNISON AXON SYSTEM is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is Miles, Inc.. The 510(k) number is K941156.

When did TECHNISON AXON SYSTEM receive FDA 510(k) clearance?

TECHNISON AXON SYSTEM received FDA 510(k) clearance on 1994-04-26, under 510(k) number K941156.

Who is the listed applicant for TECHNISON AXON SYSTEM?

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

What is the FDA product code for TECHNISON AXON SYSTEM?

The FDA product code for TECHNISON AXON SYSTEM is KHS.

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Other records listing Miles, Inc. 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.

K950292FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEMK950353TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMK950186CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMK945655CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM)K941171TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)K943376OPERA SYSTEM

View all 11 devices →

Related Devices (Code: KHS)

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.

K170200Carbon Dioxide Reagent SetTeco Diagnostics, Inc.K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd.K131546AU BICARBONATE REAGENTBeckman Coulter Ireland, Inc.K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K120765VITROS CHEMISTRY PRODUCTS ECO2 SLIDESOrtho-Clinical Diagnostics, Inc.K113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann

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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