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FDA 510(k)

MERIDIAN EBV-IGG TEST KIT

K-Number: K925689 · 1993-10-12

ApplicantFuller Laboratories, Inc.
Decision Date1993-10-12
Product CodeMCD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MERIDIAN EBV-IGG TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Fuller Laboratories, Inc.. It received FDA 510(k) clearance on 1993-10-12 under 510(k) number K925689. 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 MERIDIAN EBV-IGG TEST KIT?

MERIDIAN EBV-IGG TEST KIT is a medical device that received FDA 510(k) clearance on 1993-10-12. The listed applicant is Fuller Laboratories, Inc.. The 510(k) number is K925689.

When did MERIDIAN EBV-IGG TEST KIT receive FDA 510(k) clearance?

MERIDIAN EBV-IGG TEST KIT received FDA 510(k) clearance on 1993-10-12, under 510(k) number K925689.

Who is the listed applicant for MERIDIAN EBV-IGG TEST KIT?

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

What is the FDA product code for MERIDIAN EBV-IGG TEST KIT?

The FDA product code for MERIDIAN EBV-IGG TEST KIT is MCD.

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Other records listing Fuller 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.

K931557FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TESTK925690MERIDIAN EBNA TEST KITK925688MERIDIAN EBV-EA TEST KIT

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.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.K911570EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TESTOrtho Diagnostic Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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