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FDA 510(k)

WASHER 6000 MICRO-C LISA SYSTEM

K-Number: K831640 · 1983-08-08

Decision Date1983-08-08
Product CodeJTC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

WASHER 6000 MICRO-C LISA 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 1983-08-08 under 510(k) number K831640. 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 6000 MICRO-C LISA SYSTEM?

WASHER 6000 MICRO-C LISA SYSTEM is a medical device that received FDA 510(k) clearance on 1983-08-08. The listed applicant is Organon Teknika Corp.. The 510(k) number is K831640.

When did WASHER 6000 MICRO-C LISA SYSTEM receive FDA 510(k) clearance?

WASHER 6000 MICRO-C LISA SYSTEM received FDA 510(k) clearance on 1983-08-08, under 510(k) number K831640.

Who is the listed applicant for WASHER 6000 MICRO-C LISA 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 6000 MICRO-C LISA SYSTEM?

The FDA product code for WASHER 6000 MICRO-C LISA SYSTEM is JTC.

Related Clinical Trials

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.

Other records listing Organon Teknika Corp. 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.

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Related Devices (Code: JTC)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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