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FDA 510(k)

MODIFIED ORTHO EBV VCA-IGG ELISA

K-Number: K920412 · 1992-06-22

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1992-06-22
Product CodeMCD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED ORTHO EBV VCA-IGG ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1992-06-22 under 510(k) number K920412. 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 MODIFIED ORTHO EBV VCA-IGG ELISA?

MODIFIED ORTHO EBV VCA-IGG ELISA is a medical device that received FDA 510(k) clearance on 1992-06-22. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K920412.

When did MODIFIED ORTHO EBV VCA-IGG ELISA receive FDA 510(k) clearance?

MODIFIED ORTHO EBV VCA-IGG ELISA received FDA 510(k) clearance on 1992-06-22, under 510(k) number K920412.

Who is the listed applicant for MODIFIED ORTHO EBV VCA-IGG ELISA?

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

What is the FDA product code for MODIFIED ORTHO EBV VCA-IGG ELISA?

The FDA product code for MODIFIED ORTHO EBV VCA-IGG ELISA is MCD.

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Other records listing Ortho Diagnostic Systems, 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.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK963902QUANTITATIVE FIBRINOGEN ASSAYK950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

View all 126 devices →

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.K911571EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TESTOrtho Diagnostic Systems, Inc.K911570EPSTEIN-BARR VIRUS VCA-IGM 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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