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FDA 510(k)

CMV BIO-BEAD TITRATION KIT

K-Number: K801722 · 1980-09-16

ApplicantLitton Bionetics
Decision Date1980-09-16
Product CodeGQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CMV BIO-BEAD TITRATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Litton Bionetics. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801722. 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 CMV BIO-BEAD TITRATION KIT?

CMV BIO-BEAD TITRATION KIT is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Litton Bionetics. The 510(k) number is K801722.

When did CMV BIO-BEAD TITRATION KIT receive FDA 510(k) clearance?

CMV BIO-BEAD TITRATION KIT received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801722.

Who is the listed applicant for CMV BIO-BEAD TITRATION KIT?

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

What is the FDA product code for CMV BIO-BEAD TITRATION KIT?

The FDA product code for CMV BIO-BEAD TITRATION KIT is GQH.

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Other records listing Litton Bionetics 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.

K840417EBNA ACIF KITK834443ROTAVIRUS BIO-ENZABEAD SCREEN KITK831343CMV RQ BIO-ENZABEAD KITK822985EBV-M KITK821804RUBELLA RQ BIO-ENZABEAD KITK801720TOXO BIO-BEAD TITRATION 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.K882024FITC MURINE MONOCLONAL ANTI-CMV IGGWhittaker Bioproducts, Inc.K881932ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENTOrtho 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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