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FDA 510(k)

RUBENOSTIKA IGG MICROELISA SYSTEM

K-Number: K911393 · 1991-04-29

ApplicantOrganon Teknika Corp.
Decision Date1991-04-29
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBENOSTIKA IGG 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 1991-04-29 under 510(k) number K911393. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBENOSTIKA IGG MICROELISA SYSTEM?

RUBENOSTIKA IGG MICROELISA SYSTEM is a medical device that received FDA 510(k) clearance on 1991-04-29. The listed applicant is Organon Teknika Corp.. The 510(k) number is K911393.

When did RUBENOSTIKA IGG MICROELISA SYSTEM receive FDA 510(k) clearance?

RUBENOSTIKA IGG MICROELISA SYSTEM received FDA 510(k) clearance on 1991-04-29, under 510(k) number K911393.

Who is the listed applicant for RUBENOSTIKA IGG 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 RUBENOSTIKA IGG MICROELISA SYSTEM?

The FDA product code for RUBENOSTIKA IGG MICROELISA SYSTEM is LFX.

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Other records listing Organon Teknika Corp. as applicant

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Related Devices (Code: LFX)

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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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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