Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550

K-Number: K883601 · 1989-05-11

ApplicantClinical Sciences, Inc.
Decision Date1989-05-11
Product CodeLLM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1989-05-11 under 510(k) number K883601. The device is classified under product code LLM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550?

EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 is a medical device that received FDA 510(k) clearance on 1989-05-11. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K883601.

When did EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 receive FDA 510(k) clearance?

EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 received FDA 510(k) clearance on 1989-05-11, under 510(k) number K883601.

Who is the listed applicant for EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550?

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

What is the FDA product code for EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550?

The FDA product code for EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 is LLM.

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 Clinical Sciences, 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.

K900688VARICELLA ZOSTER IGG CLIN-ELISA TEST KITK883870EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590K883871EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590K891990RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600K883600EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550K874594TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560

View all 30 devices →

Related Devices (Code: LLM)

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.

K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A.K040120DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYSDiaSorin, Inc.K984133THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K973941IMMUNOWELL EBNA IGG TESTGenbioK980598EBNA-1 IGM ELISA TEST SYSTEMClark Laboratories, Inc.K951549EBNA IGG EIA TEST SYSTEMImmunoprobe, 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.

↑