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FDA 510(k)

CYTOMEGALOVIRUS ANTIBODY SCREEN

K-Number: K910003 · 1991-03-20

ApplicantImmucor, Inc.
Decision Date1991-03-20
Product CodeLJO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOMEGALOVIRUS ANTIBODY SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Immucor, Inc.. It received FDA 510(k) clearance on 1991-03-20 under 510(k) number K910003. The device is classified under product code LJO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOMEGALOVIRUS ANTIBODY SCREEN?

CYTOMEGALOVIRUS ANTIBODY SCREEN is a medical device that received FDA 510(k) clearance on 1991-03-20. The listed applicant is Immucor, Inc.. The 510(k) number is K910003.

When did CYTOMEGALOVIRUS ANTIBODY SCREEN receive FDA 510(k) clearance?

CYTOMEGALOVIRUS ANTIBODY SCREEN received FDA 510(k) clearance on 1991-03-20, under 510(k) number K910003.

Who is the listed applicant for CYTOMEGALOVIRUS ANTIBODY SCREEN?

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

What is the FDA product code for CYTOMEGALOVIRUS ANTIBODY SCREEN?

The FDA product code for CYTOMEGALOVIRUS ANTIBODY SCREEN is LJO.

Related Clinical Trials

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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Other records listing Immucor, 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.

K203612Capture-CMVK183571Capture-CMV

Related Devices (Code: LJO)

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.

K203612Capture-CMVImmucor, Inc.K183571Capture-CMVImmucor, Inc.K001767DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEMDiamedix Corp.K974901HYBRID CAPTURE SYSTEM CMV DNA ASSAYDigene Corp.K974456CMVGENInstrumentation Laboratory COK951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYE.I. Dupont DE Nemours & Co., 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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