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FDA 510(k)

EBV-M KIT

K-Number: K822985 · 1982-12-03

ApplicantLitton Bionetics
Decision Date1982-12-03
Product CodeJRY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV-M 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 1982-12-03 under 510(k) number K822985. The device is classified under product code JRY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBV-M KIT?

EBV-M KIT is a medical device that received FDA 510(k) clearance on 1982-12-03. The listed applicant is Litton Bionetics. The 510(k) number is K822985.

When did EBV-M KIT receive FDA 510(k) clearance?

EBV-M KIT received FDA 510(k) clearance on 1982-12-03, under 510(k) number K822985.

Who is the listed applicant for EBV-M 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 EBV-M KIT?

The FDA product code for EBV-M KIT is JRY.

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 KITK821804RUBELLA RQ BIO-ENZABEAD KITK801722CMV BIO-BEAD TITRATION KITK801721HSV BIO-BEAD TITRATION KIT

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Related Devices (Code: JRY)

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.

K042118ATHENA MULTI-LYTE EBV IGG TEST SYSTEMZeus Scientific, Inc.K900974INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.Stellar Bio Systems, Inc.K891785BION EBV-G (VCA) TEST SYSTEMBion Ent., Ltd.K884829EBV EARLY ANTIGEN (R+D)Hillcrest BiologicalsK822734EBV IGM TESTGull Laboratories, Inc.K821849EBV-VCA ANTIBODY ASSAY KITBiotech Research Laboratories, 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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