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FDA 510(k)

EBV IGG ELISA TEST

K-Number: K910872 · 1991-04-12

ApplicantGull Laboratories, Inc.
Decision Date1991-04-12
Product CodeMCD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV 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 1991-04-12 under 510(k) number K910872. The device is classified under product code MCD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBV IGG ELISA TEST?

EBV IGG ELISA TEST is a medical device that received FDA 510(k) clearance on 1991-04-12. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K910872.

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

EBV IGG ELISA TEST received FDA 510(k) clearance on 1991-04-12, under 510(k) number K910872.

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

The FDA product code for EBV IGG ELISA TEST is MCD.

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Other records listing Gull Laboratories, Inc. as applicant

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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: MCD)

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.

K984126THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K933251EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TESTVirion (U.S.), Inc.K925689MERIDIAN EBV-IGG TEST KITFuller Laboratories, Inc.K924091EBV-VCA IGG ELISA TEST SYSTEMZeus Scientific, Inc.K920412MODIFIED ORTHO EBV VCA-IGG ELISAOrtho Diagnostic Systems, Inc.K911571EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TESTOrtho Diagnostic Systems, 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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