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FDA 510(k)

TECHNICON RA-1000 SYS, ANALYTES III

K-Number: K821514 · 1982-05-10

ApplicantTechnicon Instruments Corp.
Decision Date1982-05-10
Product CodeJEJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TECHNICON RA-1000 SYS, ANALYTES III 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 1982-05-10 under 510(k) number K821514. The device is classified under product code JEJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNICON RA-1000 SYS, ANALYTES III?

TECHNICON RA-1000 SYS, ANALYTES III is a medical device that received FDA 510(k) clearance on 1982-05-10. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K821514.

When did TECHNICON RA-1000 SYS, ANALYTES III receive FDA 510(k) clearance?

TECHNICON RA-1000 SYS, ANALYTES III received FDA 510(k) clearance on 1982-05-10, under 510(k) number K821514.

Who is the listed applicant for TECHNICON RA-1000 SYS, ANALYTES III?

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-1000 SYS, ANALYTES III?

The FDA product code for TECHNICON RA-1000 SYS, ANALYTES III is JEJ.

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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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