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FDA 510(k)

IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY

K-Number: K885297 · 1989-06-23

ApplicantAbbott Laboratories
Decision Date1989-06-23
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K885297. 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 IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY?

IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Abbott Laboratories. The 510(k) number is K885297.

When did IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1989-06-23, under 510(k) number K885297.

Who is the listed applicant for IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY?

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

What is the FDA product code for IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY?

The FDA product code for IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY is LFX.

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Related Devices (Code: LFX)

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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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