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FDA 510(k)

RUBEOLA IGG ELISA TEST

K-Number: K904854 · 1990-12-04

ApplicantGull Laboratories, Inc.
Decision Date1990-12-04
Product CodeLJB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RUBEOLA 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 1990-12-04 under 510(k) number K904854. The device is classified under product code LJB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBEOLA IGG ELISA TEST?

RUBEOLA IGG ELISA TEST is a medical device that received FDA 510(k) clearance on 1990-12-04. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K904854.

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

RUBEOLA IGG ELISA TEST received FDA 510(k) clearance on 1990-12-04, under 510(k) number K904854.

Who is the listed applicant for RUBEOLA 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 RUBEOLA IGG ELISA TEST?

The FDA product code for RUBEOLA IGG ELISA TEST is LJB.

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Other records listing Gull Laboratories, Inc. 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.

K983541HSV 1+2 IGG ELISA TESTK971857MUMPS IGG ELISA TESTYK962343TOXO IGG ELISA TESTK935730EBNA IGG ELISA TESTK940093EBV-EA(D) IGG ELISA TESTK941046VZV IGG ELISA TEST

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Related Devices (Code: LJB)

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.

K974552DIAMEDIX IS-MEASLES IGG TEST SYSTEMDiamedix Corp.K971620QUANTA LITE RUBEOLA (MEASLES) IGGInova Diagnostics, Inc.K922330BARTELS RUBEOLA IGG EIABaxter Diagnostics, Inc.K922335BARTELS RUBEOLA IGM EIABaxter Diagnostics, Inc.K910290VIRATEST-DIA(TM) MEASLES (RUBEOLA)Virus Reference Laboratory, Inc.K904083RUBEOLA IGM ELISA TESTGull Laboratories, Inc.

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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