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FDA 510(k)

RUBELLA IGG ELISA TEST

K-Number: K915893 · 1992-03-04

ApplicantGull Laboratories, Inc.
Decision Date1992-03-04
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBELLA IGG ELISA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1992-03-04 under 510(k) number K915893. 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 RUBELLA IGG ELISA TEST?

RUBELLA IGG ELISA TEST is a medical device that received FDA 510(k) clearance on 1992-03-04. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K915893.

When did RUBELLA IGG ELISA TEST receive FDA 510(k) clearance?

RUBELLA IGG ELISA TEST received FDA 510(k) clearance on 1992-03-04, under 510(k) number K915893.

Who is the listed applicant for RUBELLA IGG ELISA TEST?

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

What is the FDA product code for RUBELLA IGG ELISA TEST?

The FDA product code for RUBELLA IGG ELISA TEST is LFX.

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Other records listing Gull Laboratories, Inc. 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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