FDA 510(k)

WASHER 500 MICROELISA SYSTEM

K-Number: K884695 · 1988-12-13

Decision Date1988-12-13

Product CodeJTC

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

WASHER 500 MICROELISA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1988-12-13 under 510(k) number K884695. The device is classified under product code JTC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WASHER 500 MICROELISA SYSTEM?

WASHER 500 MICROELISA SYSTEM is a medical device that received FDA 510(k) clearance on 1988-12-13. The listed applicant is Organon Teknika Corp.. The 510(k) number is K884695.

When did WASHER 500 MICROELISA SYSTEM receive FDA 510(k) clearance?

WASHER 500 MICROELISA SYSTEM received FDA 510(k) clearance on 1988-12-13, under 510(k) number K884695.

Who is the listed applicant for WASHER 500 MICROELISA SYSTEM?

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

What is the FDA product code for WASHER 500 MICROELISA SYSTEM?

The FDA product code for WASHER 500 MICROELISA SYSTEM is JTC.

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Other records listing Organon Teknika Corp. as applicant

K003104BACT/ALERT CSR K000492MDA D-DIMER K000378BACT/ALERT MB CULTURE BOTTLE K994343BACT/ALERT SV K993423BACT/ALERT SA K993421BACT/ALERT SN

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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.