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FDA 510(k)

TECHNICON RA-500 SYSTEM

K-Number: K854345 · 1985-11-26

ApplicantTechnicon Instruments Corp.
Decision Date1985-11-26
Product CodeJJC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECHNICON RA-500 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1985-11-26 under 510(k) number K854345. The device is classified under product code JJC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNICON RA-500 SYSTEM?

TECHNICON RA-500 SYSTEM is a medical device that received FDA 510(k) clearance on 1985-11-26. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K854345.

When did TECHNICON RA-500 SYSTEM receive FDA 510(k) clearance?

TECHNICON RA-500 SYSTEM received FDA 510(k) clearance on 1985-11-26, under 510(k) number K854345.

Who is the listed applicant for TECHNICON RA-500 SYSTEM?

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

What is the FDA product code for TECHNICON RA-500 SYSTEM?

The FDA product code for TECHNICON RA-500 SYSTEM is JJC.

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Other records listing Technicon Instruments Corp. as applicant

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Related Devices (Code: JJC)

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K945915AVL OMNI ANALYZERAvl Scientific Corp.K945584NOVA 16 ANALYZERNova Biomedical Corp.K943376OPERA SYSTEMMiles, Inc.K901410TECHNICON RA-2000(TM) SYSTEMTechnicon Instruments Corp.K901141PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZXBaxter Healthcare CorpK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTERAlpkem Corp.

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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