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FDA 510(k)

FITC MURINE MONOCLONAL ANTI-CMV IGG

K-Number: K882024 · 1988-08-03

ApplicantWhittaker Bioproducts, Inc.
Decision Date1988-08-03
Product CodeGQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FITC MURINE MONOCLONAL ANTI-CMV IGG is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1988-08-03 under 510(k) number K882024. The device is classified under product code GQH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FITC MURINE MONOCLONAL ANTI-CMV IGG?

FITC MURINE MONOCLONAL ANTI-CMV IGG is a medical device that received FDA 510(k) clearance on 1988-08-03. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K882024.

When did FITC MURINE MONOCLONAL ANTI-CMV IGG receive FDA 510(k) clearance?

FITC MURINE MONOCLONAL ANTI-CMV IGG received FDA 510(k) clearance on 1988-08-03, under 510(k) number K882024.

Who is the listed applicant for FITC MURINE MONOCLONAL ANTI-CMV IGG?

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

What is the FDA product code for FITC MURINE MONOCLONAL ANTI-CMV IGG?

The FDA product code for FITC MURINE MONOCLONAL ANTI-CMV IGG is GQH.

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Other records listing Whittaker Bioproducts, 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.

K911356LEGIONELLA STAT IGG/IGM TEST KITK9132123M IGE SINGLE POINT FAST TESTK904652LYME STAT M TEST KITK904893FIAX LYME M TEST KITK911473EBNA STAT TEST KITK905468PYLORI-G FIAX TEST KIT

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Related Devices (Code: GQH)

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.

K982311BARTELS CINAKIT CMV ANTIGENEMIAIntracel Corp.K964875CMV ANTIGEN CONTROL SLIDESViral Antigens, Inc.K935809CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAYLight DiagnosticsK882835INDIRECT FLUORESCENT ASSAY FOR (HCMV)Stellar Bio Systems, Inc.K881932ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENTOrtho Diagnostic Systems, Inc.K880679BION CMV-G TEST SYSTEMBion Ent., Ltd.

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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