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FDA 510(k)

EBV-VCA ANTIBODY ASSAY KIT

K-Number: K821849 · 1982-08-12

ApplicantBiotech Research Laboratories, Inc.
Decision Date1982-08-12
Product CodeJRY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV-VCA ANTIBODY ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biotech Research Laboratories, Inc.. It received FDA 510(k) clearance on 1982-08-12 under 510(k) number K821849. 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-VCA ANTIBODY ASSAY KIT?

EBV-VCA ANTIBODY ASSAY KIT is a medical device that received FDA 510(k) clearance on 1982-08-12. The listed applicant is Biotech Research Laboratories, Inc.. The 510(k) number is K821849.

When did EBV-VCA ANTIBODY ASSAY KIT receive FDA 510(k) clearance?

EBV-VCA ANTIBODY ASSAY KIT received FDA 510(k) clearance on 1982-08-12, under 510(k) number K821849.

Who is the listed applicant for EBV-VCA ANTIBODY ASSAY KIT?

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

What is the FDA product code for EBV-VCA ANTIBODY ASSAY KIT?

The FDA product code for EBV-VCA ANTIBODY ASSAY KIT is JRY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biotech Research Laboratories, 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.

K853484INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT

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.K822985EBV-M KITLitton Bionetics

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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